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

A retrospective, multicenter, single arm, post-market study to assess the clinical safety and performance of Peripherics paclitaxel-coated balloon catheter in superficial femoral and popliteal arteries - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/07/055745
Enrollment
150
Registered
2023-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I739- Peripheral vascular disease, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr P C Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Freedom from Major Adverse Events (MAE) 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)Timepoint: 30 Days—

Secondary

MeasureTime frame
All-cause mortalityTimepoint: 6 months, and 12 months;Amputation-free survival (AFS) including major, minor, and overall AFSTimepoint: 30 days, 6 months, and 12 months;CD-TLRTimepoint: 6 months, and 12 months;Change in mean Ankle Brachial Index (ABI) compared to the pre-procedureTimepoint: 30 days, 6 months, and 12 months;Device successTimepoint: Immediately upon procedure;Freedom from MAETimepoint: 6 months, and 12 months;Improvement in Rutherford classification compared to the pre-procedureTimepoint: 30 days, 6 months, and 12 months;Major target limb amputationTimepoint: 6 months, and 12 months;Primary patencyTimepoint: 6 months, and 12 months;Procedural successTimepoint: Immediately upon discharge;Technical successTimepoint: Immediately upon procedure—

Countries

India

Contacts

Public ContactDr P C Gupta

CARE Hospitals

pcguptavascular@gmail.com9848053220

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026