Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (PFAST-CTOs)

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

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion
• Intervention / Treatment: Device: CTO Crossing and Percutaneous transluminal angioplasty

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
      • St. Luke's Medical Center
  • California
    • Los Angeles, California, United States
      • University of Southern California Medical Center
    • Torrance, California, United States
      • Torrance Memorial Medical Center
  • Colorado
    • Denver, Colorado, United States
      • University of Colorado Denver
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University Medical Center
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Prairie Cardiovascular Consultants
  • New York
    • New York, New York, United States
      • Columbia University Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States
      • Wake Heart Center
  • Texas
    • Dallas, Texas, United States
      • Dallas VA Medical Center
  • Washington
    • Bellingham, Washington, United States
      • St. Joseph Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)

Collaborators and Investigators

• Sponsor: BridgePoint Medical
• Investigators: Principal Investigator: William A Gray, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: November 19, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 23, 2010

Study Record Updates

• Last Update Posted (Estimate): July 12, 2012
• Last Update Submitted That Met QC Criteria: July 11, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 200-0012