iCover covered stents used as bridging stents during fenestrated endovascular repair for complex abdominal aortic aneurysms

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

This trial will test whether the iCover balloon-expandable covered stent works safely and reliably as a bridging stent to connect renal and other visceral arteries during fenestrated endovascular repair in people with complex abdominal aortic aneurysms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 55 Years and up
• Sex: All
• Sponsor: iVascular S.L.U. (Industry-sponsored)
• Locations: 24 sites (Bonheiden and 23 other locations)
• Trial ID: NCT07529275 on ClinicalTrials.gov

What this trial studies

fenCo is a prospective, multicentre European study that implants the iCover balloon-expandable covered stent as a bridging stent into reno-visceral target vessels during fenestrated endovascular aortic repair (fEVAR). Participating vascular centers will place iCover stents through fenestrations aligned with target vessel orifices and follow patients with clinical and imaging assessments. Key outcomes include procedural success, stent patency, renal function, endoleak rates, and device-related complications. The protocol requires adherence to the Instructions for Use of the chosen fenestrated endograft systems and captures data to document safety and performance of the device.

Who should consider this trial

Good fit: Ideal candidates are adults with juxta-, para-renal, suprarenal, or thoracoabdominal complex abdominal aortic aneurysms planned for fEVAR with fenestrations positioned within 5 mm of the target vessel orifice and who meet the device and endograft Instructions for Use.

Not a fit: Patients whose anatomy does not allow fenestrations to lie within 5 mm of the target vessel, who are better served by open repair, or who fall outside the IFUs of the fenestrated endograft or iCover stent are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could improve durable vessel sealing and patency after fEVAR and reduce the need for reinterventions related to bridging stents.

How similar studies have performed: Bridging covered balloon-expandable stents have been used in fEVAR with generally acceptable patency in prior series, but prospective multicentre evidence specifically for the iCover device is limited.

Eligibility criteria

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.

Where this trial is running

Bonheiden and 23 other locations

• 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)

Conditions Complex Abdominal Aortic Aneurysms; FEVAR; bridging stent; complex abdominal aortic aneurysms