Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-02 @ 9:36 AM
Study NCT ID:
NCT00712257
Status:
TERMINATED
Last Update Posted:
2014-06-04
First Post:
2008-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-09-23', 'releaseDate': '2015-08-24'}], 'estimatedResultsFirstSubmitDate': '2015-08-24'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Due to safety concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-02', 'studyFirstSubmitDate': '2008-07-03', 'studyFirstSubmitQcDate': '2008-07-08', 'lastUpdatePostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Target lesion revascularization will be evaluated at 12 mos. and defined as any pecutaneous or surgical intervention to treat a stenosis or cocclusion of the arget lesion treated at the index procedure.', 'timeFrame': '12 month follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['treatment of superficial femoral artery instent restenosis'], 'conditions': ['Restenosis']}, 'descriptionModule': {'briefSummary': 'A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject or subject's legal representative informed of the study nature.\n* Subject understands the duration of the study and its follow up visit requirements.\n* Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.\n* Subject able to walk unassisted.\n* Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.\n\nExclusion Criteria:\n\n* Life expectancy less than 12 months\n* Myocardial infarction less than 3 months prior to procedure\n* Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.\n* Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.\n* Uncontrolled hypercoagulability"}, 'identificationModule': {'nctId': 'NCT00712257', 'acronym': 'SALVAGE', 'briefTitle': 'Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis', 'organization': {'class': 'OTHER', 'fullName': 'VIVA Physicians'}, 'officialTitle': 'A Prospective, Multicenter Trial to Evaluate the Safety and Performance of Spectranetics Laser With Adjunct PTA and GORE VIABAHN Endoprosthesis for the Treatment of SFA Instent Restenosis.', 'orgStudyIdInfo': {'id': 'SALVAGE - 00106-661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Spectranetics Laser plus Gore Viabahn Endoprosthesis', 'description': 'Spectranetics Laser for optimal debulking followed by adjunctive PTA plus GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface placement', 'interventionNames': ['Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface']}], 'interventions': [{'name': 'Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface', 'type': 'DEVICE', 'description': 'treatment for superficial femoral artery instent re-stenosis', 'armGroupLabels': ['Spectranetics Laser plus Gore Viabahn Endoprosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gary Ansel, MD', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Tony Das, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Presbyterian Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIVA Physicians', 'class': 'OTHER'}, 'collaborators': [{'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, {'name': 'Spectranetics Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-08-24', 'type': 'RELEASE'}, {'date': '2015-09-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'VIVA Physicians'}}}}