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Clinical Trials in Germany / NCT05192616
Active, not recruiting Observational

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

NCT05192616 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2022-04-27
Last updated
2025-05-16

Condition(s) studied

AngioplastyPeripheral Arterial DiseaseIliac Artery DiseaseCovered StentAorto-Iliac Atherosclerosis

Investigational drug(s) / intervention(s)

Covered stent implantation

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

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Onze Lieve Vrouw Aalst Aalst Belgium
Imelda Bonheiden Bonheiden Belgium
Az Sint Blasius Dendermonde Dendermonde Belgium
ZOL Genk Genk Belgium
Centre Hospitalier Universitaire de Brest Brest France
CHU Pitié Salpêtrière Paris France
Hôpital Paris Saint Joseph Paris France
Hôpital privé Saint-Martin Pessac France
Hôpital privé Villeneuve d'Ascq Villeneuve-d'Ascq France
Herzzentrum Bad Krozingen Bad Krozingen Baden-Wurttemberg
MVZ Kaiserslautern Kaiserslautern Rhineland-Palatinate
Universitätsklinikum Leipzig Leipzig Saxony
KEH Berlin Berlin Germany
Imland Klinik Rendsburg Rendsburg Germany
Hospital de Santa Creu i Sant Pau Barcelona Spain
Hospital Universitari Germans Trias i Pujol Barcelona Spain
Hospital de Cruces Bilbao Spain
Hospital Parc Taulí Sabadell Spain

More iVascular S.L.U. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05192616 on ClinicalTrials.gov ↗ ← All trials in Germany