Post-market study of safety and performance of the Peripherics paclitaxel-coated balloon catheter in superficial femoral and popliteal arteries.
- Conditions
- Health Condition 1: I739- Peripheral vascular disease, unspecified
- Registration Number
- CTRI/2023/07/055745
- Lead Sponsor
- Dr P C Gupta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or non-pregnant, non-breastfeeding female =18 years of age
2. Rutherford Clinical Category 2-5
3. Patients who treated with at least one Peripherics paclitaxel-coated balloon catheter in superficial femoral and/or popliteal arteries as described in the Instruction for Use (IFU)
4. Target lesion(s) must either be de-novo or non-stented re-stenotic lesion(s). If the target lesion(s) is re-stenotic, the prior PTA must have been done > 30 days prior-index procedure
1. Life expectancy of less than 1-year
2. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet
3. Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure
4. Previously implanted stent in target lesion(s)
5. Previous procedure with drug-coated balloons in the target vessel(s) within 6 months prior to index procedure
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method