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Real-World, Registry to Evaluate the Effectiveness, Safety and Durability of SUPERA Stent for the Treatment of De Novo or Restenotic Superficial Femoral Artery or Complex Femoropopliteal Artery Lesions

A Prospective, Multicentric, Non- Interventional Real-World, Data Collection Registry to Evaluate the Effectiveness, Safety and Durability of SUPERA Stent for the Treatment of De Novo or Restenotic Superficial Femoral Artery or Complex Femoropopliteal Artery Lesions in Indian patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/09/021451
Enrollment
500
Registered
2019-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

None listed

Sponsors

Dr Rajiv Parakh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex aged =18 years. 2. Patients willing to sign the informed consent form (ICF) to share the data. 3. Patients with de novo or restenotic lesions in the superficial femoral artery or femoropopliteal segment treated successfully ( <30% diameter stenosis with no procedural complications) with SUPERA stent.

Exclusion criteria

Exclusion criteria: 1. Patients unwilling to sign the ICF. 2. Patients with age 90 years. 3. Patients with other comorbidities that may limit life expectancy to less than one year.

Design outcomes

Primary

MeasureTime frame
1. Percentage of patients free from TLR at 12 months after the index interventionTimepoint: 12 months—

Secondary

MeasureTime frame
Percentage of patients with a patent index vessel at 12 months, Percentage of patients who died from any cause (all-cause death), Percentage of patients with stent fractures on radiographic screening at 12 months after the index procedure, Change in clinical status of the patient (assessed by Rutherford-Becker classification) from baseline, at 12 months after the index intervention, Change in quality of life from baseline to 12 months after the index interventionTimepoint: 12 months—

Countries

India

Contacts

Public ContactDr Rajiv Parakh

Medanta - The Medicity

parakhsupreme@gmail.com9811047390

Outcome results

None listed

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