Clinical trial NCT05192616: Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Angioplasty
Peripheral Arterial Disease
Iliac Artery Disease
Covered Stent
Aorto-Iliac Atherosclerosis
Lead sponsor: iVascular S.L.U.
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5). Patients with de novo atheromatous aorto-iliac lesions.

According to the incidence of TASC II lesions, approximately 70% of the patients will be classified as TASC II A or B lesions, while the other 30% will be classified as TASC II C or D lesions.

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.

Eligibility criteria: Inclusion criteria

1. ≥ 18 years of age
2. Rutherford clinical stage 2 to 5
3. Significant (≥70%) stenosis of atheromatous iliac lesions evidenced by duplex scan, MRI CT angiography or arteriography
4. De novo atheromatous lesion of the aortoiliac segment
5. Patient informed about the study and collection of the patient's informed consent agreement Exclusion criteria

Subjects will not be eligible to participate in the study if any of the following conditions are present in the subject:

1. Protected adult patients, guardianship, curatorship, safeguard of justice
2. Woman with possibility of pregnancy
3. Patient with asymptomatic atheromatous lesions
4. Patient with inflow lesion in the infrarenal aorta
5. Patient treated with Covered endovascular reconstruction of aortic bifurcation (CERAB reconstruction)
6. Acute ischemia or acute thrombosis
7. Non-atherosclerotic disease
8. History of coagulopathy
9. Severe comorbidities with life expectancy \<2 years
10. Contraindication to taking antiplatelet aggregation therapy (aspirin or clopidogrel). The patient must be able to take an antiplatelet aggregation for at least 3 months after the procedure
11. Patient participating in another clinical study which may interfere with the results
12. Comorbidity or any reason which, according to the investigator, could limit the participation, the patient's adherence with the follow-up or the scientific integrity of the study
13. Lesion near or adjacent to an aneurysm
14. Inability to follow-up during the investigation
15. Patient objection to participate in the investigation

Primary outcomes:
measure: Primary Patency
timeFrame: 12 months after index procedure.
Secondary outcomes:
measure: Technical success rate
timeFrame: Day 0.
measure: Procedural success rate
timeFrame: Day 0.
measure: Freedom from All Major Adverse Event (MAEs)
timeFrame: 1, 6, 12, 24 months after index procedure.
measure: Incidence of Procedure- or Device- related Major Local Complications
timeFrame: Up to 30 days after index procedure.
measure: Rates of Serious Adverse Events (SAEs)
timeFrame: 1, 6, 12, 24 months after index procedure.
measure: Major amputation at target limb rate
timeFrame: 1, 6, 12, 24 months after index procedure.
measure: Primary sustained clinical improvement
timeFrame: 1, 6, 12, 24 months after index procedure.
measure: Primary patency rates
timeFrame: 6 and 24 months after index procedure.
measure: Secondary patency rates
timeFrame: 6, 12, 24 months after index procedure.
measure: Target lesion revascularization (TLR) rate
timeFrame: 1, 6, 12, 24 months after index procedure.
measure: Target vessel revascularization (TVR) rate
timeFrame: 1, 6, 12, 24 months after index procedure.
measure: Change in Ankle-Brachial Index (ABI) from baseline
timeFrame: 1, 6, 12, 24 months post-procedure.
measure: Change in Walking Impairment Questionnaire from baseline
timeFrame: 1, 6, 12, 24 months post-procedure.
measure: Change in quality of life from baseline
timeFrame: 1, 6, 12, 24 months post-procedure.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Aalst
city: Bonheiden
country: Belgium
facility: Imelda Bonheiden
city: Dendermonde
country: Belgium
facility: Az Sint Blasius Dendermonde
city: Genk
country: Belgium
facility: ZOL Genk
city: Brest
country: France
facility: Centre Hospitalier Universitaire de Brest
city: Paris
country: France
facility: CHU Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Paris Saint Joseph
city: Pessac
country: France
facility: Hôpital privé Saint-Martin
city: Villeneuve-d'Ascq
country: France
facility: Hôpital privé Villeneuve d'Ascq
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
state: Baden-Württemberg
city: Kaiserslautern
country: Germany
facility: MVZ Kaiserslautern
state: Rhineland-Palatinate
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Saxony
city: Berlin
country: Germany
facility: KEH Berlin
city: Rendsburg
country: Germany
facility: Imland Klinik Rendsburg
city: Barcelona
country: Spain
facility: Hospital de Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
Study officials:
References: