A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries in Patients Undergoing Hemodialysis
Phase 3
- Conditions
- Symptomatic occlusive disease of the peripheral arteries
- Registration Number
- JPRN-UMIN000014673
- Lead Sponsor
- Medicon Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
1. History of stroke within 3 months; 2. History of MI, thrombolysis or angina within 30 days of enrollment; 3. Prior or planned major amputation (of either leg); etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method