Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2026-03-05 @ 9:41 AM
Study NCT ID:
NCT01663818
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2012-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tack Optimized Balloon Angioplasty (TOBA) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-02', 'studyFirstSubmitDate': '2012-08-06', 'studyFirstSubmitQcDate': '2012-08-09', 'lastUpdatePostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '30 days', 'description': 'Composite of new-onset major device-related adverse events.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Peripheral Vascular Disease']}, 'descriptionModule': {'briefSummary': 'A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).', 'detailedDescription': 'Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rutherford clinical category 2, 3 or 4\n* ABI less than or equal to 0.90\n* Reference vessel diameter is between 2.5mm and 5.5mm\n* Target lesion has stenosis greater than or equal to 70% or is occluded\n* Target lesion is less than or equal to 10cm in length\n\nExclusion Criteria:\n\n* Previously implanted stent in the ipsilateral superficial femoral or popliteal artery\n* Target treatment area is severly calcified (e.g. circumferential calcification or calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm continuously)'}, 'identificationModule': {'nctId': 'NCT01663818', 'acronym': 'TOBA', 'briefTitle': 'Tack Optimized Balloon Angioplasty (TOBA) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Clinical & Medical Affairs Global'}, 'officialTitle': 'Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler', 'orgStudyIdInfo': {'id': 'TD 0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Treatment with Tack-IT Endovascular Staple', 'interventionNames': ['Device: Tack-It Endovascular Stapler']}], 'interventions': [{'name': 'Tack-It Endovascular Stapler', 'type': 'DEVICE', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Patrick Peeters, MD', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}], 'overallOfficials': [{'name': 'Marc Bosiers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Blasius Hospital'}, {'name': 'Dierk Scheinert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Park Hospital, Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Clinical & Medical Affairs Global', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}