Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Chronic Total Occlusion Clinical Trial

— PFAST-CTOs  

Official title:

Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246505
• Other study ID #: 200-0012
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2010
• Last updated: July 11, 2012
• Start date: July 2011
• Est. completion date: January 2012

Study information

• 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

Clinical Trial Summary

Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Total Occlusion

Intervention

Device:
• CTO Crossing and Percutaneous transluminal angioplasty
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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
BridgePoint Medical

Country where clinical trial is conducted

United States, 

Outcome

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