Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-22 @ 11:42 PM
Study NCT ID:
NCT02568293
Status:
UNKNOWN
Last Update Posted:
2017-02-09
First Post:
2015-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], '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'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2015-10-01', 'studyFirstSubmitQcDate': '2015-10-02', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events', 'timeFrame': 'through 24 weeks', 'description': 'The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment:\n\n* Index limb amputation (above or below the ankle)\n* Index limb re-intervention\n* Index-limb-related death'}, {'measure': 'Late Lumen Loss', 'timeFrame': '24 weeks', 'description': 'LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.', 'detailedDescription': 'This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for balloon angioplasty for stenosis of femoropopliteal lesion(s)\n* Rutherford Clinical Category 1-4 (claudication or critical limb ischemia)\n* Lesions are ≥70% stenosis by visual estimate\n* A patent inflow artery free from significant lesion\n* At least one patent native outflow artery to the ankle\n\nExclusion Criteria:\n\n* History of haemorrhagic stroke within 3 months of screening\n* History of myocardial infarction, thrombolysis or angina within 2 weeks of screening\n* Renal failure or chronic kidney disease\n* Severe calcification that renders the lesion undilatable'}, 'identificationModule': {'nctId': 'NCT02568293', 'acronym': 'SHIELD', 'briefTitle': 'Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Symic Vascular'}, 'officialTitle': 'A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery', 'orgStudyIdInfo': {'id': 'TP-1601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBCV', 'description': 'SBCV is administered to the site immediately post balloon dilation.', 'interventionNames': ['Other: SBCV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Saline is used as a control and is delivered immediately post balloon dilation.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'SBCV', 'type': 'OTHER', 'description': 'SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.', 'armGroupLabels': ['SBCV']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Saline is used as a control.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Melbourne', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital'}, {'zip': '2065', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast University Hospital', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '5043', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Center', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '3181', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Symic Vascular', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Symic Biomedical, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}