Viewing Study NCT00706394

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Ignite Creation Date: 2025-12-25 @ 1:34 AM
Ignite Modification Date: 2025-12-27 @ 6:52 AM
Study NCT ID: NCT00706394
Status: COMPLETED
Last Update Posted: 2021-11-01
First Post: 2008-05-02
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: 34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'strifskin@endologix.com', 'phone': '949-599-8860', 'title': 'Sharone Trifskin', 'organization': 'Endologix'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 Years', 'eventGroups': [{'id': 'EG000', 'title': 'Powerlink 34mm Cuff Stent Graft', 'description': 'Powerlink 34mm cuff stent graft\n\nEndologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 7, 'seriousNumAtRisk': 19, 'deathsNumAffected': 6, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Vision problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Postop ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Peri rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Burning down left anterior leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Mild erythema left knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Right inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Endoleak Type I distal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Endoleak Type II IMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Left distal endoleak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Type I endoleak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Type I endoleak - placement aortic stent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Lung nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Pulmonary congestion postop', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Severe Pulmonary Enphisema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'ABO Sugical Incisional Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Incisional pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Left groin bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Removal of sternal wire - non healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Carotid endoarterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Carotid Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Elevated velocity left internal carotid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Renal Artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Increased Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Decreased Hematocrit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Triple Vessel Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Cholecystis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Erosive Gastritis/Epgastric Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'GI Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Vomiting, Diarrhea, Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Increased Ascites secondary to cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Lieus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Pseudomembraneous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Non cardiac CP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Left groin incision infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'MRSA left lower leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Compression Fracture of Lumbar Spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Brain Tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Metastatic Lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Metastatic Brain tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Side branch-type pancreatic papillary mucinous neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Stage IV small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Left lower lung mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Endoleak with Increased aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Limb extension right distal leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Type I endoleak requiring endovascular repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Major depression recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Right leg ulcer and tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Translumbar embolization of AAA sac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Aneurysm increased >/=5mm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Coagulopathy: decreased platelets due to HIT+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Ischemic Left Leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Left femoral-popliteal bypass with graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}, {'term': 'Right femoral tibial bypass for gangrenous foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom Coding'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Proximal Type I Endoleak at Each Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy', 'description': 'Powerlink 34mm cuff stent graft\n\nEndologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '1 Month', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '48 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '60 Months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Five years', 'description': 'Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Successful Delivery and Deployment of the Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy', 'description': 'Powerlink 34mm cuff stent graft\n\nEndologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Month', 'description': 'Successful delivery and deployment of the device with no complication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Type III Endoleaks at Each Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy', 'description': 'Powerlink 34mm cuff stent graft\n\nEndologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '48 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '60 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 Years', 'description': 'Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results are provided as the number of events over the number of patients with the follow-up image available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stent Fracture at Each Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy', 'description': 'Powerlink 34mm cuff stent 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{'title': 'CABG', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'PTCA/Stent', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Renal Failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Smoking (ever)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Valvular Disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Valve Replacement', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Aneurysm Diameter Distribution', 'classes': [{'categories': [{'title': '<30mm', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '30mm to 39mm', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '40mm to 49mm', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '50mm to 59mm', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '60mm to 69mm', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '70mm to 79mm', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>79mm', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Aneurysm Measurements', 'classes': [{'title': 'External Iliac Diameter', 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.2', 'groupId': 'BG000'}]}]}, {'title': 'Proximal non-aneurysmal neck diameter', 'categories': [{'measurements': [{'value': '28', 'spread': '1.9', 'groupId': 'BG000'}]}]}, {'title': 'Distal non-aneurysmal neck diameter', 'categories': [{'measurements': [{'value': '31', 'spread': '1.4', 'groupId': 'BG000'}]}]}, {'title': 'Maximum Aneurysm Diameter', 'categories': [{'measurements': [{'value': '57', 'spread': '12', 'groupId': 'BG000'}]}]}, {'title': 'Proximal non-aneurysmal right iliac diameter', 'categories': [{'measurements': [{'value': '15', 'spread': '2.7', 'groupId': 'BG000'}]}]}, {'title': 'Distal non-aneurysmal right iliac diameter', 'categories': [{'measurements': [{'value': '13', 'spread': '2.3', 'groupId': 'BG000'}]}]}, {'title': 'Proximal non-aneurysmal left iliac diameter', 'categories': [{'measurements': [{'value': '15', 'spread': '3.4', 'groupId': 'BG000'}]}]}, {'title': 'Distall non-aneurysmal left iliac diameter', 'categories': [{'measurements': [{'value': '13', 'spread': '2.6', 'groupId': 'BG000'}]}]}, {'title': 'Proximal Seal Zone lenght', 'categories': [{'measurements': [{'value': '27', 'spread': '11', 'groupId': 'BG000'}]}]}, {'title': 'Length Proximal Neck to Left Proximal Iliac', 'categories': [{'measurements': [{'value': '122', 'spread': '21', 'groupId': 'BG000'}]}]}, {'title': 'Length Proximal Neck to Distal Right Iliac', 'categories': [{'measurements': [{'value': '171', 'spread': '23', 'groupId': 'BG000'}]}]}, {'title': 'Length Proximal Neck to Distal Left Iliac', 'categories': [{'measurements': [{'value': '169', 'spread': '23', 'groupId': 'BG000'}]}]}, {'title': 'Right Distal Seal Zone Length', 'categories': [{'measurements': [{'value': '41', 'spread': '13', 'groupId': 'BG000'}]}]}, {'title': 'Left Distal Seal Zone Length', 'categories': [{'measurements': [{'value': '38', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants received a commercially available 28mm Powerlink infrarenal bifurcated stent graft and a 34mm infrarental proximal cuff'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2008-05-02', 'resultsFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2008-06-26', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-23', 'studyFirstPostDateStruct': {'date': '2008-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Proximal Type I Endoleak at Each Timepoint', 'timeFrame': 'Five years', 'description': 'Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Successful Delivery and Deployment of the Device', 'timeFrame': '1 Month', 'description': 'Successful delivery and deployment of the device with no complication.'}, {'measure': 'Number of Participants With Type III Endoleaks at Each Timepoint', 'timeFrame': '5 Years', 'description': 'Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.'}, {'measure': 'Number of Participants With Stent Fracture at Each Timepoint', 'timeFrame': '5 Years', 'description': 'Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab.'}, {'measure': 'Number of Participants With Stent Graft Obstruction at Each Timepoint', 'timeFrame': '5 Years', 'description': 'Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab.'}, {'measure': 'Number of Participants With Migration at Each Timepoint', 'timeFrame': '5 Years', 'description': 'Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.'}, {'measure': 'Number of Participants With Type II Endoleaks at Each Timepoint', 'timeFrame': '5 Years', 'description': 'Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.'}, {'measure': 'Number of Participants With Aneurysm Diameter Change at Each Timepoint', 'timeFrame': '5 Years', 'description': 'Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab.'}, {'measure': 'Maximum Diameter Measurements', 'timeFrame': '5 Years', 'description': 'Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).'}, {'measure': 'Aneurysm Volume Measurements', 'timeFrame': '5 Years', 'description': 'Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Powerlink', '34mm', 'Abdominal Aortic Aneurysm', 'EVAR'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '19679425', 'type': 'RESULT', 'citation': 'Jordan WD Jr, Moore WM Jr, Melton JG, Brown OW, Carpenter JP; Endologix Investigators. Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg. 2009 Nov;50(5):979-86. doi: 10.1016/j.jvs.2009.05.057. Epub 2009 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'Study of anatomical fixation with a 34mm proximal extension', 'detailedDescription': 'The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years old or older\n* Informed consent understood and signed\n* Will comply with protocol follow-up requirements\n* Candidate for conventional open surgical repair\n* Aneurysm outer diameter is one or more of the following:\n\n * greater than or equal to 4.0cm\n * greater than or equal to 3.0cm (saccular aneurysm)\n * greater than or equal to twice the normal aortic outer diameter\n * rapidly growing (greater than or equal to 5mm over 6 months)\n* Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm\n* Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm\n* Iliac artery internal diameter greater than or equal to 8 mm\n\nExclusion Criteria:\n\n* Life expectancy \\<2 years\n* Participating in another clinical study\n* Pregnant or lactating women\n* Acutely ruptured/leaking aneurysm\n* Traumatic vascular injury\n* Other medical or psychiatric problems\n* Contraindication to non-ionic contrast media or anticoagulants\n* Coagulopathy or bleeding disorder\n* Active systemic or localized groin infection\n* Indispensable inferior mesenteric artery\n* Connective tissue disease (e.g., Marfan's Syndrome)\n* Creatinine level \\>1.7 mg/dl\n* Renal transplant patient\n* Proximal attachment site \\>60º angle to the aneurysm body\n* Iliac arteries \\>90º angle\n* \\<1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides \\[One internal iliac artery is required to remain patent\\]\n* Thrombus \\>30% at implantation site"}, 'identificationModule': {'nctId': 'NCT00706394', 'briefTitle': '34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endologix'}, 'officialTitle': 'Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms', 'orgStudyIdInfo': {'id': 'CP03-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Powerlink 34mm cuff stent graft', 'interventionNames': ['Device: Endologix Powerlink 34 mm stent graft cuff']}], 'interventions': [{'name': 'Endologix Powerlink 34 mm stent graft cuff', 'type': 'DEVICE', 'otherNames': ['Endologix Powerlink 34mm cuff [model 34-34-80L]'], 'description': 'Endovascular abdominal aortic aneurysm repair', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33140', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cardiac and Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Hospital East', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'St. Joseph Medical Center', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Heart Institute', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Sisters of Charity Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Cardiovascular Associates', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital at the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29169', 'city': 'West Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Lexington Medical Center', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}], 'overallOfficials': [{'name': 'Edward Y Woo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States'}, {'name': 'O. W. Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'William Beaumont Hospital, Royal Oak, MI 48073, United States'}, {'name': 'James G. Melton, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma Cardiovascular Research Group, Oklahoma City, OK 73120, United States'}, {'name': 'Steven H. Tyndall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nebraska Heart Hospital, Lincoln, NE 68526, United States'}, {'name': 'William M. Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lexington Medical Center, West Columbia, SC 29169, United States'}, {'name': 'Salem George, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baptist Hospital East, Louisville, KY 40207, United States'}, {'name': 'Kerry C. Prewitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Joseph Medical Center, Towson, MD 21204, United States'}, {'name': 'Paul Anain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sisters of Charity Hospital, Buffalo, NY 14214, United States'}, {'name': 'Robert Beasley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Medical Center, Miami Beach, FL 33140, United States'}, {'name': 'Barry T. Katzen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baptist Cardiac and Vascular Institute, Miami, FL 33176, United States'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endologix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}