A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
Phase 3
- Conditions
- Symptomatic occlusive disease of the peripheral arteries
- Registration Number
- JPRN-UMIN000010358
- Lead Sponsor
- Medicon Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
Not provided
Exclusion Criteria
-Life expectancy of < 2 years -History of hemorrhagic stroke within 3 months -Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure -History of MI, thrombolysis or angina within 2 weeks of enrollment -Renal failure or chronic kidney disease -Severe calcification that renders the lesion un-dilatable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Patency at 6 months.
- Secondary Outcome Measures
Name Time Method Primary and Secondary Patency Target Lesion Revascularization (TLR) Rutherford classification Resting Ankle Brachial Index rate (ABI) Walking Impairment Questionnaire Quality of life score Death Amputation (above the ankle)-Free Survival (AFS) Target Vessel Revascularization (TVR) Major vascular complications