Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Completed · Phase 3

Conditions studied: Chronic Total Occlusion

In brief

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

Key facts

Study ID

NCT01246505

Run by

BridgePoint Medical

People needed

105

Starts

2011-07-01

Expected to finish

2012-01-01

Last updated by the study team

2012-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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