Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

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

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