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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Bridging stent patency at 12-month visit [Срок оценки: 12 months visit]
• Absence of target vessel instability between implantation and 12-month visit. [Срок оценки: starting at implant day through the study completion, with an average of 12Months up to 14Months per window.]

Вторичные конечные точки (12)

• Technical success: Successful introduction and deployment of the iCover stent implanted as bridging stent in FEVAR procedure. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: discharge visit, 6 and 12 months visits.]
• 30-day post-procedure mortality. [Срок оценки: within 30 days post procedure]
• In-hospital post-procedure mortality (all causes). [Срок оценки: between procedure and 12 months visit]
• Absence of aortic endograft migration at 6 months visit and at 12 months visit. [Срок оценки: at 6 and 12 months visits]
• No increase in maximum aneurysmal sac diameter measured by CT angiography at 6 and at 12 months visits. [Срок оценки: at 6 and 12 months visits]
• Absence of post-procedural aortic surgical conversion at discharge, at 6 and 12 months visits. [Срок оценки: between implant and 6 and 12 months visits]
• Absence of aneurysm-related mortality post-procedure at discharge, at 6 months and 12 months visits. [Срок оценки: between implant and 6 and 12 months visits]
• Absence of aneurysm related secondary endovascular procedures at discharge, at 6 and 12 months visits. [Срок оценки: between implant 6 and 12 months visits.]

Критерии участия

Критерии включения

• 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:

• Cook Medical: Zenith Fenestrated AAA Endovascular Graft
• Terumo Aortic: TREO and Anaconda Fenestrated Stent Grafts
• JOTEC (part of Artivion): E-xtra design engineering.
• 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.

Критерии исключения

• Patients contraindicated for anti-platelet therapy.
• Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia.
• Chronic or acute aortic dissection.
• Patients refusing treatment.
• Patients who are pregnant or wish to become pregnant.
• Patients scheduled for major or life-saving surgery within 30 days of the fenestrated stent procedure.
• Patients considered hemodynamically unstable or requiring emergency treatment.
• Patients with severe arteriopathy leading to adverse outflow, which may impair bridging stent patency on the targeted artery.
• Thrombus in the aortic sealing zone and target arteries with thickness > to 3 mm.
• Stenosis (>50%) or occlusion of target arteries or distal disease resulting in poor iCover stent outflow.
• Patients allergic to stent materials (L605) and/or PTFE.
• Patients requiring a hybrid aortic technique with branches, semibranches or chimneys.
• Patient who has been implanted with any stent type or brand other than iCover as a bridging stent in any target artery.
• Patients with infectious/mycotic aneurysms.
• Angulation between renal artery and aortic wall < 30 degrees.
• 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.
• 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.
• Myocardial infarction or stroke within 3 months prior to the procedure.
• Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4.
• Patients with ASA classification 5 or higher.
• Patients with physician modified endografts or in situ laser FEVAR.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 8 центров

• CHU BORDEAUX-Hopital Tripode — Bordeaux
• CHU BREST- la Cavale Blanche — Brest
• CHU LILLE- Institut Cœur Poumon — Lille
• APHM- Hôpital De La Timone — Marseille
• Hôpital St Joseph — Marseille
• Nouvel Hôpital Privé les Franciscaines — Nîmes
• CHU TOULOUSE- Hôpital Rangueil — Toulouse
• Hôpital privé de Villeneuve d'Ascq — Villeneuve-d'Ascq

Бельгия · 7 центров

• Imelda Ziekenhuis — Bonheiden
• ZOL GENK — Genk
• Maria Middelares GENT — Ghent
• UZ GENT — Ghent
• Grand hopital Saint Josep — Gilly
• Jessa Hasselt — Hasselt
• Chu Liege — Liège

Германия · 6 центров

• University Hospital Cologne — Cologne
• Asklepios Klinik St. Georg — Hamburg
• Universitätsklinik Hamburg Eppendorf — Hamburg
• Uni-Klinikum Leipzig — Leipzig
• LMU München Campus Großhadern — München
• TUM Munich — München

Нидерланды · 2 центра

• Amsterdam UMC — Amsterdam
• University Medical Center Groningen — Groningen

Испания · 1 центр

• Hospital Clinic - University of Barcelona — Barcelona

Идентификаторы

NCT: NCT07529275 · FenCo-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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