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

iVascular S.L.U.165 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

165

Conditions

Complex Abdominal Aortic Aneurysms

Interventions

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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.

Locations (24)

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

...and 14 more locations

Outcomes

Primary Outcomes

Bridging stent patency at 12-month visit

Defined as rate of stents with an absence of binary restenosis (≥ 50% stenosis) based on CT Angio at 12 months visit (+/-2 months).

Time frame: 12 months visit

Absence of target vessel instability between implantation and 12-month visit.

Defined as rate of patients with an absence of target vessel instability described as a composite endpoint of any branch-related complication leading to: aneurysm rupture/ death/ occlusion/ component separation/ or reintervention to maintain branch patency or to treat a branch-related component separation or endoleak between implantation and 12 months visit (+/-2 months).

Time frame: starting at implant day through the study completion, with an average of 12Months up to 14Months per window.

Secondary Outcomes

Technical success: Successful introduction and deployment of the iCover stent implanted as bridging stent in FEVAR procedure.

Defined as rate of stents with successful introduction and deployment of the iCover (iVascular) implanted as bridging stent in FEVAR.

Time frame: During the index procedure (from stent introduction to final deployment, up to procedure completion)

Bridging stent patency at the first postoperative imaging, at 6 and at 12 months visits.

Defined as rate of stents without binary restenosis \> 50% or occlusion on duplex scan and/or angioCT scan examination, or angiography at discharge at 6 and 12 months visits.

Time frame: at discharge visit (up to 3 months, average of 7days) and at 6 and 12 months visits ( can be up to 8 and 14months from implant day)

Absence of endoleaks linked to iCover covered stent defects at the first postoperative imaging, at 6 and 12 months visits.

Defined as rate of stents without endoleaks linked to iCover covered stent defects (Malposition, rupture or disconnection) on Duplex scan, angio CTscan or angiography at discharge visit, at 6 months visits and at 12 months visit.

Time frame: discharge visit , 6 and 12 months visits.

Absence of re-intervention due to a technical defect in iCover covered stents at discharge, at 6 months visit, and at 12 months visit.

Defined as rate of stents without re-intervention due to a technical defect in iCover covered stents post-procedure between surgery and post operative to discharge period, between surgery and 6 months visit, between surgery and 12 months visit.

Time frame: between surgery and post operative to discharge period, between surgery and 6 months visit, between surgery and 12 months visit.

Absence of type I or III endoleaks post-procedure at the first postoperative imaging, at 6 and 12 months visits.

Defined as rate of stents without type I or III endoleaks post-procedure on duplex scan, angio CTscan or angiography at discharge period, 6 months visit and at 12 months visit.

Time frame: discharge visit, 6 and 12 months visits.

30-day post-procedure mortality.

Defined as rate of post-procedure mortality (all causes) within 30-day post procedure.

Time frame: within 30 days post procedure

In-hospital post-procedure mortality (all causes).

Defined as rate of In-hospital post-procedure mortality (all causes).

Time frame: between procedure and 12 months visit

Absence of aortic endograft migration at 6 months visit and at 12 months visit.

Defined as rate of endografts without aortic migration \> 10 mm at 6 Months visit and 12 months visit.

Time frame: at 6 and 12 months visits

No increase in maximum aneurysmal sac diameter measured by CT angiography at 6 and at 12 months visits.

Defined as rate of patients without increase of \> 5 mm in maximum aneurysmal sac diameter compared with post-procedure angio CT scan measured by angio CT scan at 6 and 12 months visits.

Time frame: at 6 and 12 months visits

Absence of post-procedural aortic surgical conversion at discharge, at 6 and 12 months visits.

Defined as absence of post-procedural aortic surgical conversion between the implantation and the follow-up visits

Time frame: between implant and 6 and 12 months visits

Absence of aneurysm-related mortality post-procedure at discharge, at 6 months and 12 months visits.

Defined as absence of aneurysm-related mortality post-procedure between the implantation and the follow-up visits.

Time frame: between implant and 6 and 12 months visits

Absence of aneurysm related secondary endovascular procedures at discharge, at 6 and 12 months visits.

Defined as absence of aneurysm related secondary endovascular procedures between the implantation and the follow-up visits.

Time frame: between implant 6 and 12 months visits.

Absence of major adverse events (MAEs) at discharge, at 6 and 12 months visits.

Defined as aortic rupture, aneurysm-related death, in-hospital death, decline in renal function (by at least 20%), lower extremity ischemia, mesenteric ischemia, or unplanned reintervention between the implantation and the follow-up visits.

Time frame: between implant and 6, 12 months vists.

Absence of target vessel instability at 12 months visit.

Time frame: at 12 months visit

Target vessel patency at at 6 and 12 months visits

Defined as proportion of target vessel patency at 6 and 12 months.

Time frame: 6 and 12 months visits