Post-market study of safety and performance of the Peripherics paclitaxel-coated balloon catheter in superficial femoral and popliteal arteries.

Active, not recruiting

• Conditions: Peripheral vascular disease, unspecified,

• Registration Number: CTRI/2023/07/055745
• Lead Sponsor: Dr P C Gupta

Brief Summary

This is a retrospective, observational, multicenter, single arm, investigator initiated, post-market study, designed to assess the clinical safety and performance of Peripherics paclitaxel-coated balloon catheter in SFA and/or PA during routine clinical practice. All consecutive patients, with claudication or ischemic rest pain and documented diagnosis of peripheral arterial disease in SFA and/or PA classified as Rutherford class 2-5, either who had been treated with Peripherics paclitaxel-coated balloon catheter at least 6 months prior **or** who will be treated with Peripherics paclitaxel-coated balloon catheter within 6 months after the starting date of the retrospective anonymous data collection will be included in this study. This study has been designed for academic research purpose only and has no impact on the patient’s routine standard of care.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-08
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
Freedom from Major Adverse Events (MAE)	30 Days
Freedom from MAE defined as, a composite of freedom from all-cause mortality, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (CD-TLR)	30 Days

Secondary Outcome Measures

Name	Time	Method
Freedom from MAE	6 months, and 12 months
Primary patency	6 months, and 12 months
All-cause mortality	6 months, and 12 months
Major target limb amputation	6 months, and 12 months
CD-TLR	6 months, and 12 months
Improvement in Rutherford classification compared to the pre-procedure	30 days, 6 months, and 12 months
Change in mean Ankle Brachial Index (ABI) compared to the pre-procedure	30 days, 6 months, and 12 months
Device success	Immediately upon procedure
Technical success	Immediately upon procedure
Procedural success	Immediately upon discharge
Amputation-free survival (AFS) including major, minor, and overall AFS	30 days, 6 months, and 12 months

Trial Locations

Locations (2)

CARE Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

CARE Hospitals

🇮🇳Hyderabad, TELANGANA, India

Dr P C Gupta

Principal investigator

9848053220

pcguptavascular@gmail.com