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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCover balloon-expandable covered peripheral stent system | Experimental | iCover balloon-expandable covered peripheral stent system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCover balloon-expandable covered peripheral stent system as bridging stent | Device | This device will be used as bridging stent during FEVAR (fenestrated endovascular aortic repair) procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | starting at implant day through the study completion, with an average of 12Months up to 14Months per window. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the index procedure (from stent introduction to final deployment, up to procedure completion) |
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Inclusion Criteria:
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).
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.
Anatomy and patient strictly in accordance with the Instructions For Use (IFU) of the fenestrated endograft chosen to be implanted:
Additional iCover stent, if necessary, could be placed in the same target artery (2 iCovers stents max as bridging stent for each fenestration).
Landing zone in the target vessel of at least 10 mm.
Target arteries (renal arteries, superior mesenteric artery, celiac trunk) with a diameter between 5 and 10 mm.
Angulation of the aorta at the level of the target vessels < 45 degrees.
No early significant branching from the target vessel with a potential risk of coverage and subsequent significant risk of target organ infarctions.
Age > 55 years.
Patient having notified his consent to this study and willing to comply with specified follow-up evaluations at the specified times.
Patient affiliated to or benefiting from a social security system.
Patient with life expectancy > 12 months.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Ziekenhuis | Not yet recruiting | Bonheiden | 2820 | Belgium |
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| 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. | 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. | 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. | 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. | 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. | within 30 days post procedure |
| In-hospital post-procedure mortality (all causes). | Defined as rate of In-hospital post-procedure mortality (all causes). | 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. | 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. | 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 | 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. | 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. | 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. | between implant and 6, 12 months vists. |
| Absence of target vessel instability at 12 months visit. | Absence of target vessel instability at 12 months visit. | 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. | 6 and 12 months visits |
| ZOL GENK | Not yet recruiting | Genk | 3600 | Belgium |
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| Maria Middelares GENT | Not yet recruiting | Ghent | 9000 | Belgium |
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| UZ GENT | Not yet recruiting | Ghent | 9000 | Belgium |
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| Grand hopital Saint Josep | Not yet recruiting | Gilly | 6060 | Belgium |
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| Jessa Hasselt | Not yet recruiting | Hasselt | 3800 | Belgium |
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| Chu Liege | Not yet recruiting | Liège | B-4000 | Belgium |
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| CHU BORDEAUX-Hopital Tripode | Recruiting | Bordeaux | 33076 | France |
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| CHU BREST- la Cavale Blanche | Not yet recruiting | Brest | 29200 | France |
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| CHU LILLE- Institut Cœur Poumon | Not yet recruiting | Lille | 59000 | France |
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| APHM- Hôpital De La Timone | Not yet recruiting | Marseille | 13005 | France |
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| Hôpital St Joseph | Not yet recruiting | Marseille | 13008 | France |
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| Nouvel Hôpital Privé les Franciscaines | Not yet recruiting | Nîmes | 30000 | France |
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| CHU TOULOUSE- Hôpital Rangueil | Not yet recruiting | Toulouse | 31400 | France |
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| Hôpital privé de Villeneuve d'Ascq | Not yet recruiting | Villeneuve-d'Ascq | 59650 | France |
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| University Hospital Cologne | Not yet recruiting | Cologne | 50937 | Germany |
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| Asklepios Klinik St. Georg | Not yet recruiting | Hamburg | 20099 | Germany |
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| Universitätsklinik Hamburg Eppendorf | Not yet recruiting | Hamburg | 20246 | Germany |
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| Uni-Klinikum Leipzig | Not yet recruiting | Leipzig | 04103 | Germany |
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| LMU München Campus Großhadern | Not yet recruiting | München | 81377 | Germany |
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| TUM Munich | Not yet recruiting | München | 81675 | Germany |
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| Amsterdam UMC | Not yet recruiting | Amsterdam | 1105 | Netherlands |
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| University Medical Center Groningen | Not yet recruiting | Groningen | 9700 | Netherlands |
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| Hospital Clinic - University of Barcelona | Not yet recruiting | Barcelona | 08036 | Spain |
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