Prospective, Multicenter, Non-randomized, Single-arm Observational Study to Evaluate Safety and Effectiveness of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Angioplasty
- Sponsor
- iVascular S.L.U.
- Enrollment
- 241
- Locations
- 18
- Primary Endpoint
- Primary Patency
- Status
- Active, Not Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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).
Detailed Description
This is a prospective, single-arm, multinational, and multicenter study conducted to evaluate the safety and efficacy of the iCover covered stent for the treatment of de novo iliac occlusive lesions (common and/or external iliac arteries) in patients with symptomatic lower limb arteriopathy. The primary endpoint of the study is primary patency, defined as the absence of restenosis in the target lesion over a 12-month follow-up period in patients who did not undergo a reintervention on the target lesion. Restenosis is defined as a reduction in the luminal diameter of more than 50%, assessed either by duplex ultrasound (considered as a peak systolic velocity index ≥ 2.4 at the target lesion) or by angio-CT (multiplanar reconstruction). Secondary endpoints include: technical and procedural success rate, freedom from all major adverse events, incidence of procedure- or device-related major local complications at the treated lesion, rate of SAEs, major amputation rate at the target limb, primary sustained clinical improvement (improvement in Rutherford classification), primary and secondary patency rates, TLR and TVR rates, and changes in ABI, the Walking Impairment Questionnaire, and the EQ-5D questionnaire from baseline.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Patency
Time Frame: 12 months after index procedure.
The primary patency, defined as the absence of restenosis in the target lesion over the 12-month follow-up period in patients who did not undergo a reintervention on the target lesion.
Secondary Outcomes
- Procedural success rate(Day 0.)
- Rates of Serious Adverse Events (SAEs)(1, 6, 12, 24 months after index procedure.)
- Major amputation at target limb rate(1, 6, 12, 24 months after index procedure.)
- Change in Walking Impairment Questionnaire from baseline(1, 6, 12, 24 months post-procedure.)
- Freedom from All Major Adverse Event (MAEs)(1, 6, 12, 24 months after index procedure.)
- Target lesion revascularization (TLR) rate(1, 6, 12, 24 months after index procedure.)
- Technical success rate(Day 0.)
- Primary sustained clinical improvement(1, 6, 12, 24 months after index procedure.)
- Incidence of Procedure- or Device- related Major Local Complications(Up to 30 days after index procedure.)
- Primary patency rates(6 and 24 months after index procedure.)
- Secondary patency rates(6, 12, 24 months after index procedure.)
- Target vessel revascularization (TVR) rate(1, 6, 12, 24 months after index procedure.)
- Change in Ankle-Brachial Index (ABI) from baseline(1, 6, 12, 24 months post-procedure.)
- Change in quality of life from baseline(1, 6, 12, 24 months post-procedure.)