Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-15 @ 4:39 AM
Study NCT ID:
NCT01246505
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2010-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-11', 'studyFirstSubmitDate': '2010-11-19', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Patients with a Major Adverse Events (MAE)', 'timeFrame': '30 Day', 'description': 'MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication.'}, {'measure': 'Incidence of Intraprocedural Technical Success', 'timeFrame': 'Intraprocedural (<24 hours)', 'description': 'Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Total Occlusion']}, 'descriptionModule': {'briefSummary': 'Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suitable candidate for non-emergent, peripheral angioplasty\n* documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply)\n* limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery\n\nExclusion Criteria:\n\n* intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel\n* appearance of thrombus or intraluminal filling defects\n* peripheral intervention in the target limb within two weeks of the procedure\n* renal insufficiency (serum creatinine of \\> 2.3 mg/dl)\n* contraindication to a peripheral artery intervention\n* participation in another investigational protocol'}, 'identificationModule': {'nctId': 'NCT01246505', 'acronym': 'PFAST-CTOs', 'briefTitle': 'Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions', 'organization': {'class': 'INDUSTRY', 'fullName': 'BridgePoint Medical'}, 'officialTitle': 'Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions', 'orgStudyIdInfo': {'id': '200-0012'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CTO Crossing and Percutaneous transluminal angioplasty', 'type': 'DEVICE', 'description': "Crossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion)"}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Memorial Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Medical Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Cardiovascular Consultants', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Heart Center', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Bellingham', 'state': 'Washington', 'country': 'United States', 'facility': 'St. Joseph Hospital', 'geoPoint': {'lat': 48.75955, 'lon': -122.48822}}], 'overallOfficials': [{'name': 'William A Gray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BridgePoint Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}