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

Study acronym: iliCo
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 16, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: May 30, 2024 to Jun 2025 Primary endpoint revised · Trial status: Not Yet Recruiting to Active, Not Recruiting · Enrollment target: estimated 214 to confirmed 241 · 6 morev2 Show 9 more changesShow less
    • Primary endpoint revised
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 214 to confirmed 241
    • Completion date: May 30, 2025 to Jun 2026
    • Start date changed from estimate of Feb 15, 2022 to Apr 27, 2022
    • Secondary endpoints: 8 to 14
    • Study description expanded, about 182 words
    • Study sites revised (18)
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05192616
Lead Sponsor iVascular S.L.U.
Conditions Angioplasty, Peripheral Arterial Disease, Iliac Artery Disease, Covered Stent, Aorto-Iliac Atherosclerosis
Enrollment 241 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov