A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent
Phase 3
- Conditions
- Symptomatic occlusive disease of the peripheral arteries
- Registration Number
- JPRN-UMIN000009551
- Lead Sponsor
- Medicon Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1. The subject has concomitant renal failure with a creatinine of >2.5 mg/dl or having dialysis treatment. 2. Subject has a history of bypass surgery on the study vessel. 3. Subject has a history of MI or stroke within 6 months of study procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects who are free of target limb failure at 12-months post study procedure.
- Secondary Outcome Measures
Name Time Method Primary patency, Secondary patency, Rutherford category assessment, ABI, Quality of life measurements, Major Adverse Events, all AEs and SAEs, TVR/TLR rates, and Freedom from Stent fracture rate