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Clinical Trials in Germany / NCT07529275
Recruiting Not applicable

Clinical Performance and Safety Assessment of the Use of iCover Balloon Expandable Covered Stent (iVascular) Implanted as Bridging Stent in FEVAR (Fenestrated Endovascular Aortic Repair) for the Treatment of Complex Abdominal Aortic Aneurysms

NCT07529275 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2026-02-16
Last updated
2026-04-14

Condition(s) studied

Complex Abdominal Aortic Aneurysms

Investigational drug(s) / intervention(s)

iCover balloon-expandable covered peripheral stent system as bridging stent

iCover balloon-expandable covered peripheral stent system as bridging stent: This device will be used as bridging stent during FEVAR (fenestrated endovascular aortic repair) procedures.

Study summary

fenCo is a European multicentre, prospective study to evaluate the use of the iCover covered stents as bridging stents for reno-visceral target vessel during fEVAR for the treatment of complex abdominal aortic aneurysms.

Eligibility

Sex
ALL
Min age
55 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient suitable for treatment of a juxta, para-renal, suprarenal or thoracoabdominal aneurysm with a fenestrated endoprosthesis in accordance with current indications and guidelines for the management of abdominal aortic aneurysms (aneurysm \> 5 centimetres for women and \> 5.5 centimetres for men and/or growth \> 5 mm in 6 months or 1 centimetre in 1 year). 2. The fenestrated endograft must be designed in a way that positions the fenestrations directly in front of the orifice of the target vessel, ensuring that the distance between the fenestration and the orifice of the target vessel does not exceed 5 mm. 3. Anatomy and patient strictly in accordance with the Instructions For Use (IFU) of the fenestrated endograft chosen to be implanted: 1. Cook Medical: Zenith Fenestrated AAA Endovascular Graft 2. Terumo Aortic: TREO and Anaconda Fenestrated Stent Grafts 3. JOTEC (part of Artivion): E-xtra design engineering. 4. Additional iCover stent, if necessary, could be placed in the same target artery (2 iCovers stents max as bridging stent for each fenestration). 5. Landing zone in the target vessel of at least 10 mm. 6. Target arteries (renal arteries, superior mesenteric artery, celiac trunk) with a diameter between 5 and 10 mm. 7. Angulation of the aorta at the level of the target vessels \< 45 degrees. 8. No early significant branching from the target vessel with a potential risk of coverage and subsequent significant risk of target organ infarctions. 9. Age \> 55 years. 10. Patient having notified his consent to this study and willing to comply with specified follow-up evaluations at the specified times. 11. Patient affiliated to or benefiting from a social security system. 12. Patient with life expectancy \> 12 months. Exclusion Criteria: 1. Patients contraindicated for anti-platelet therapy. 2. Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia. 3. Chronic or acute aortic dissection. 4. Patients refusing treatment. 5. Patients who are pregnant or wish to become pregnant. 6. Patients scheduled for major or life-saving surgery within 30 days of the fenestrated stent procedure. 7. Patients considered hemodynamically unstable or requiring emergency treatment. 8. Patients with severe arteriopathy leading to adverse outflow, which may impair bridging stent patency on the targeted artery. 9. Thrombus in the aortic sealing zone and target arteries with thickness \> to 3 mm. 10. Stenosis (\>50%) or occlusion of target arteries or distal disease resulting in poor iCover stent outflow. 11. Patients allergic to stent materials (L605) and/or PTFE. 12. Patients requiring a hybrid aortic technique with branches, semibranches or chimneys. 13. Patient who has been implanted with any stent type or brand other than iCover as a bridging stent in any target artery. 14. Patients with infectious/mycotic aneurysms. 15. Angulation between renal artery and aortic wall \< 30 degrees. 16. Patients with complex iliac accesses out the IFUs of the fenestrated endograft chosen to be implanted (COOK Medical / Terumo Aortic/Jotec-Artivion) with the iCover Bridging stent. 17. Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period that may interfere with the results of this study. 18. Myocardial infarction or stroke within 3 months prior to the procedure. 19. Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4. 20. Patients with ASA classification 5 or higher. 21. Patients with physician modified endografts or in situ laser FEVAR.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Imelda Ziekenhuis Bonheiden Belgium Not Yet Recruiting
ZOL GENK Genk Belgium Not Yet Recruiting
Maria Middelares GENT Ghent Belgium Not Yet Recruiting
UZ GENT Ghent Belgium Not Yet Recruiting
Grand hopital Saint Josep Gilly Belgium Not Yet Recruiting
Jessa Hasselt Hasselt Belgium Not Yet Recruiting
Chu Liege Liège Belgium Not Yet Recruiting
CHU BORDEAUX-Hopital Tripode Bordeaux France Recruiting
CHU BREST- la Cavale Blanche Brest France Not Yet Recruiting
CHU LILLE- Institut Cœur Poumon Lille France Not Yet Recruiting
APHM- Hôpital De La Timone Marseille France Not Yet Recruiting
Hôpital St Joseph Marseille France Not Yet Recruiting
Nouvel Hôpital Privé les Franciscaines Nîmes France Not Yet Recruiting
CHU TOULOUSE- Hôpital Rangueil Toulouse France Not Yet Recruiting
Hôpital privé de Villeneuve d'Ascq Villeneuve-d'Ascq France Not Yet Recruiting
University Hospital Cologne Cologne Germany Not Yet Recruiting
Asklepios Klinik St. Georg Hamburg Germany Not Yet Recruiting
Universitätsklinik Hamburg Eppendorf Hamburg Germany Not Yet Recruiting
Uni-Klinikum Leipzig Leipzig Germany Not Yet Recruiting
LMU München Campus Großhadern München Germany Not Yet Recruiting
TUM Munich München Germany Not Yet Recruiting
Amsterdam UMC Amsterdam Netherlands Not Yet Recruiting
University Medical Center Groningen Groningen Netherlands Not Yet Recruiting
Hospital Clinic - University of Barcelona Barcelona Spain Not Yet Recruiting

More iVascular S.L.U. trials in Germany

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 NCT07529275 on ClinicalTrials.gov ↗ ← All trials in Germany