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

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

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.

In terms of complex endovascular repair, fenestrated stent grafts should be considered the preferred treatment option when feasible. The main advantage of Fenestrated Endovascular Aneurysm Repair (fEVAR) lies in the avoidance of aortic cross clamping and subsequent lower risk of renal dysfunction, less surgical trauma and faster recovery, which may be advantageous for patients at high risk for open surgery. fenCo study aims to demonstrate the safety and efficacy of iCover when used as bridging stent in fEVAR procedures for the treatment of complex abdominal aortic aneurysms.

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.