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

BridgePoint Medical

Status and phase: Completed; Phase 3

Conditions: Chronic Total Occlusion

Treatments: Device: CTO Crossing and Percutaneous transluminal angioplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT01246505

200-0012

Details and patient eligibility

About

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

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)