Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-31 @ 8:34 AM
Study NCT ID:
NCT00768495
Status:
UNKNOWN
Last Update Posted:
2009-06-04
First Post:
2008-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperspectral Imaging Pre and Post Endovascular Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-02', 'studyFirstSubmitDate': '2008-10-06', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['revascularization', 'claudication', 'hyperspectral', 'oxygenation', 'limb ischemia'], 'conditions': ['Chronic Limb Ischemia', 'Non-Healing Ulcers']}, 'referencesModule': {'references': [{'pmid': '17397438', 'type': 'BACKGROUND', 'citation': 'Ostchega Y, Paulose-Ram R, Dillon CF, Gu Q, Hughes JP. Prevalence of peripheral arterial disease and risk factors in persons aged 60 and older: data from the National Health and Nutrition Examination Survey 1999-2004. J Am Geriatr Soc. 2007 Apr;55(4):583-9. doi: 10.1111/j.1532-5415.2007.01123.x.'}, {'pmid': '17377162', 'type': 'BACKGROUND', 'citation': 'White C. Clinical practice. Intermittent claudication. N Engl J Med. 2007 Mar 22;356(12):1241-50. doi: 10.1056/NEJMcp064483. No abstract available.'}, {'pmid': '5476754', 'type': 'BACKGROUND', 'citation': 'Yao ST. Haemodynamic studies in peripheral arterial disease. Br J Surg. 1970 Oct;57(10):761-6. doi: 10.1002/bjs.1800571016. No abstract available.'}, {'pmid': '17385388', 'type': 'BACKGROUND', 'citation': 'Begelman SM, Jaff MR. Noninvasive diagnostic strategies for peripheral arterial disease. Cleve Clin J Med. 2006 Oct;73 Suppl 4:S22-9. doi: 10.3949/ccjm.73.suppl_4.s22.'}, {'pmid': '1246689', 'type': 'BACKGROUND', 'citation': 'Raines JK, Darling RC, Buth J, Brewster DC, Austen WG. Vascular laboratory criteria for the management of peripheral vascular disease of the lower extremities. Surgery. 1976 Jan;79(1):21-9.'}], 'seeAlsoLinks': [{'url': 'http://www.hypermed-inc.com', 'label': 'Sponsor and OxyVu technology website'}]}, 'descriptionModule': {'briefSummary': 'This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.', 'detailedDescription': 'This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have chronic limb ischemia and present with the symptoms of claudication, rest pain or having minor non-healing ulcers or gangrene (Rutherford category 1 to 6) who also require percutaneous endovascular revascularization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization.\n2. Age group between 50-85\n3. Gender - Male or Female\n4. Race - all race and ethnicities\n\nExclusion Criteria:\n\n1. Patients with known cardiac disease - new MI (within 3 months).\n2. Patients with hypertension with the systolic BP \\>200 or diastolic BP\\>110 on the day of testing\n3. Patients on supplemental O2 for chronic obstructive lung disease\n4. Bed-ridden subjects - either due to chronic disability or neurological problems'}, 'identificationModule': {'nctId': 'NCT00768495', 'acronym': 'CLI-Pre/Post', 'briefTitle': 'Hyperspectral Imaging Pre and Post Endovascular Intervention', 'organization': {'class': 'INDUSTRY', 'fullName': 'HyperMed'}, 'officialTitle': 'Evaluation of the Success of Endovascular Peripheral Revascularization for the Treatment of Chronic Limb Ischemia by Measuring OxyHb and DeoxyHb Using a New Hyperspectral Imaging Device (OxyVu).', 'orgStudyIdInfo': {'id': '2008-023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'One Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dipankar Mukherjee, MD', 'role': 'CONTACT', 'phone': '703-280-5858', 'phoneExt': '1111'}], 'facility': 'Cardiac, Vascular & Thoracic Surgery Associates', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'centralContacts': [{'name': 'Kevin Scomacker, PhD', 'role': 'CONTACT', 'email': 'kschomacker@hypermed-inc.com', 'phone': '781-229-5900'}], 'overallOfficials': [{'name': 'Kevin Schomacker, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HyperMed'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HyperMed', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Kevin Schomacker', 'oldOrganization': 'HyperMed, Inc.'}}}}