Chronic Total Occlusion Clinical Trial
— PFAST-CTOsOfficial title:
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Verified date | July 2012 |
Source | BridgePoint Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
Status | Completed |
Enrollment | 105 |
Est. completion date | January 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - suitable candidate for non-emergent, peripheral angioplasty - documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply) - limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery Exclusion Criteria: - intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel - appearance of thrombus or intraluminal filling defects - peripheral intervention in the target limb within two weeks of the procedure - renal insufficiency (serum creatinine of > 2.3 mg/dl) - contraindication to a peripheral artery intervention - participation in another investigational protocol |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University Medical Center | Atlanta | Georgia |
United States | St. Joseph Hospital | Bellingham | Washington |
United States | Dallas VA Medical Center | Dallas | Texas |
United States | University of Colorado Denver | Denver | Colorado |
United States | University of Southern California Medical Center | Los Angeles | California |
United States | Columbia University Medical Center | New York | New York |
United States | St. Luke's Medical Center | Phoenix | Arizona |
United States | Wake Heart Center | Raleigh | North Carolina |
United States | Prairie Cardiovascular Consultants | Springfield | Illinois |
United States | Torrance Memorial Medical Center | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
BridgePoint Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Patients with a Major Adverse Events (MAE) | MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication. | 30 Day | Yes |
Primary | Incidence of Intraprocedural Technical Success | Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO | Intraprocedural (<24 hours) | No |
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