Status:
COMPLETED
Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Chronic Total Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries.
Eligibility Criteria
Inclusion
- Claudication or critical limb ischemia (Rutherford Category 2-5)
- Documented de novo or re-occluded Chronic Total Occlusion (CTO) (99-100% stenosed) lesion in native femoropopliteal artery
- Target vessel occlusion length is ≥ 1 cm and ≤ 30 cm
- Minimum reference vessel diameter is 4 mm
Exclusion
- Contraindication to an endovascular procedure
- Previous stent placement in the target vessel
- Prior surgery of the superficial femoral artery (SFA) in the target limb to treat atherosclerotic disease
- Platelet count \<150,000 mm3 or \>600,000 mm3
- Renal insufficiency with a serum creatinine \>2.3 mg/dl
- History of major amputation (ankle level or above) in the same limb as the target lesion
- Current participation in another drug or device clinical study
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01500031
Start Date
April 1 2012
End Date
May 1 2013
Last Update
April 15 2014
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