Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
Study NCT ID:
NCT01330628
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2011-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000800', 'term': 'Angioplasty, Balloon'}], 'ancestors': [{'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amanda.johnson@spnc.com', 'phone': '(719) 447-2000', 'title': 'Amanda Johnson, VP of Regulatory & Medical Affairs', 'organization': 'Spectranetics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through 1 year', 'description': 'Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.', 'eventGroups': [{'id': 'EG000', 'title': 'Laser Atherectomy and PTA', 'description': 'laser, then balloon angioplasty\n\nTurbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty', 'otherNumAtRisk': 170, 'otherNumAffected': 88, 'seriousNumAtRisk': 170, 'seriousNumAffected': 117}, {'id': 'EG001', 'title': 'Balloon Angioplasty', 'description': 'Balloon angioplasty: standard balloon catheters for PTA', 'otherNumAtRisk': 82, 'otherNumAffected': 34, 'seriousNumAtRisk': 82, 'seriousNumAffected': 56}], 'otherEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood related disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Infection SAEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac SAEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other SAEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal SAEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological SAEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood related disorder SAEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular SAEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 48}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Atherectomy and PTA', 'description': 'laser, then balloon angioplasty\n\nTurbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty'}, {'id': 'OG001', 'title': 'Balloon Angioplasty', 'description': 'Balloon angioplasty: standard balloon catheters for PTA'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.', 'unitOfMeasure': '# of participants free from TLR', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed for this endpoint does not match with the Participant Flow 6 Month Follow-up population. A subject may not complete a 6 Month Follow-up due to missing the visit, being lost to follow-up, etc., but if they had a TLR prior to this time point, they would still be included in this outcome analysis.'}, {'type': 'PRIMARY', 'title': 'Freedom From Major Adverse Events (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser Atherectomy and PTA', 'description': 'laser, then balloon angioplasty\n\nTurbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty'}, {'id': 'OG001', 'title': 'Balloon Angioplasty', 'description': 'Balloon angioplasty: standard balloon catheters for PTA'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).', 'unitOfMeasure': '# of participants free from MAE', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed for this endpoint does not match with the Participant Flow 30 Day Follow-up population. If a subject did not complete a 30 Day Follow-up due to missing the visit or lost to follow-up, but had an MAE prior to this time point, they would still be included in this outcome analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laser Atherectomy and PTA', 'description': 'laser, then balloon angioplasty\n\nTurbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty'}, {'id': 'FG001', 'title': 'Balloon Angioplasty', 'description': 'Balloon angioplasty: standard balloon catheters for PTA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': '30 Day Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': '6 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': "Didn't receive study treatment", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Laser Atherectomy and PTA', 'description': 'laser, then balloon angioplasty\n\nTurbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty'}, {'id': 'BG001', 'title': 'Balloon Angioplasty', 'description': 'Balloon angioplasty: standard balloon catheters for PTA'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '67.9', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-19', 'studyFirstSubmitDate': '2011-04-04', 'resultsFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2011-04-06', 'lastUpdatePostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-04', 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From Target Lesion Revascularization (TLR)', 'timeFrame': '6 months', 'description': 'Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.'}, {'measure': 'Freedom From Major Adverse Events (MAE)', 'timeFrame': '30 days', 'description': 'Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peripheral arterial disease', 'in stent restenosis', 'peripheral vascular disease'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '25499305', 'type': 'DERIVED', 'citation': 'Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR Investigators. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):92-101. doi: 10.1016/j.jcin.2014.09.009. Epub 2014 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PAD with Rutherford class 1-4\n* Resting ABI \\<0.9 or abnormal exercise ABI \\<0.9\n* History of previous femoropopliteal nitinol stenting\n* Angiographic significant restenosis (\\>=50%)\n* Target lesion length \\>=4 cm; no more than 3 cm outside stent at either end\n* Vessel diameter \\>=5 mm and \\<=7 mm\n* At least one widely patent tibial or peroneal artery to the foot\n\nExclusion Criteria:\n\n* Patient is pregnant or breast feeding\n* Evidence of acute limb ischemia\n* Life expectancy \\<12 months\n* CVA within 60 days of screening\n* Myocardial infarction within 60 days of procedure\n* Known allergy to contract media\n* Known contraindication to aspirin, antiplatelet and anti-coagulation therapies\n* Uncontrolled hypercoagulability\n* Present or suspected systemic infection in target limb\n* Serum creatinine \\>= 2.5 mg/dl unless dialysis dependent\n* Previous treatment to target vessel within 3 months of study procedure\n* Drug eluting stents or covered stents in target lesion\n* Ipsilateral and/or contralateral iliac stenosis \\>= 50% DS that is not successfully treated prior to index procedure or with final residual stenosis \\<= 30% documented by angiography\n* Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up\n* Identification of any lesion below the target stent in the treated leg \\>50% that will require preplanned or predicted treatment within 30 days(prior to the 6 month follow up)\n* Tibial artery containing a \\>50% Diameter Stenosis (DS) by visual estimate after popliteal\n* Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.'}, 'identificationModule': {'nctId': 'NCT01330628', 'acronym': 'EXCITE ISR', 'briefTitle': 'Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectranetics Corporation'}, 'officialTitle': 'EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis', 'orgStudyIdInfo': {'id': 'D013474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser atherectomy and PTA', 'description': 'laser, then balloon angioplasty', 'interventionNames': ['Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Balloon angioplasty', 'interventionNames': ['Procedure: Balloon angioplasty']}], 'interventions': [{'name': 'Turbo Elite Laser and Turbo Tandem Laser Guide Catheters', 'type': 'DEVICE', 'description': 'application of laser energy to remove blockage followed by standard balloon angioplasty', 'armGroupLabels': ['Laser atherectomy and PTA']}, {'name': 'Balloon angioplasty', 'type': 'PROCEDURE', 'description': 'standard balloon catheters for PTA', 'armGroupLabels': ['Balloon angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "St. Vincent's East", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36533', 'city': 'Fairhope', 'state': 'Alabama', 'country': 'United States', 'facility': 'Thomas Hospital', 'geoPoint': {'lat': 30.52297, 'lon': -87.90333}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'St. Vincent Heart Clinic Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Heart Hospital', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC-Davis Medical Centers', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale - New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'The Cardiac and Vascular Institute', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Regional Hospital', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33140', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '62874', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': "St. John's Hospital", 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Hospital', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Genesis Health System', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '71111', 'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Consultants', 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'zip': '70506', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Medical center of Acadiana', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '70570', 'city': 'Opelousas', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Opelousas General Hospital', 'geoPoint': {'lat': 30.53353, 'lon': -92.08151}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Steward - St. Elizabeth's", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': "St. John's - Providence Hospital", 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '49519', 'city': 'Wyoming', 'state': 'Michigan', 'country': 'United States', 'facility': 'Metro Health Hospital', 'geoPoint': {'lat': 42.91336, 'lon': -85.70531}}, {'zip': '39401', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Hattiesburg Clinic', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart and Lung', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '284001', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Coastal Surgery Specialists', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bryn Mawr', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '02904', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Wellmont Holston Valley Medical', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Presbyterian Hospital of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Cardiac and Endovascular Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cardiac and Endovascular Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Providence Health Center', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '53212', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wheaton Franciscan Healthcare - All Saints Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '00926', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Transcatheter Medical Inc.', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Eric J Dippel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Genesis Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spectranetics Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}