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SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients

NCT03452293 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2022-11-02

No results posted yet for this study

Summary

The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our conclusions and therefore establish the generalizability of this strategy.

Conditions

  • PAD

Interventions

DEVICE

Stent Peripheral System

Peripheral PTA with Supera Stent implantation

Sponsors & Collaborators

  • Fondazione Italiana Vascolare

    collaborator OTHER

  • EndoCore Lab s.r.l.

    lead OTHER

Principal Investigators

  • Maria Salomone, MD · EndoCore Lab

  • Mariano L Palena, MD · Casa di Cura Abano Terme

  • Larry J Diaz, MD,PhD · Metro Health Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2022-03-28
Completion
2022-03-28

Countries

  • United States
  • Argentina
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452293 on ClinicalTrials.gov