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Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease

NCT05192616 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 241

Last updated 2025-05-16

No results posted yet for this study

Summary

The objective of this prospective, multi-center, non-randomized, single-arm observational study is to evaluate the safety and the efficacy of the iCover covered stent over a 24-month follow-up period for the treatment of de novo iliac occlusive lesions, defined by a significant vessel stenosis ≥70%, in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).

Conditions

  • Angioplasty
  • Peripheral Arterial Disease
  • Iliac Artery Disease
  • Covered Stent
  • Aorto-Iliac Atherosclerosis

Interventions

DEVICE

Covered stent implantation

Percutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions

Sponsors & Collaborators

  • iVascular S.L.U.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • Belgium
  • France
  • Germany
  • Spain

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 NCT05192616 on ClinicalTrials.gov