complex abdominal aortic aneurysms A complex abdominal aortic aneurysm is a dangerous ballooning of the body’s main blood vessel in the belly, but in a spot that’s harder to fix because it’s near important branches or shaped in a difficult way.
Conditions
Interventions
The iVascular iCover balloon-expandable covered peripheral 
Sponsors
iVascular S.L.U
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteriaPatient 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:a. Cook Medical: Zenith Fenestrated AAA Endovascular Graft b. Terumo Aortic: TREO and Anaconda Fenestrated Stent Grafts4. Additional iCover stent, if necessary, could be placed in the same target artery (1 or 2 max iCovers stents 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
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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is defined as the proportion of stents with an absence of binary restenosis (= 50% stenosis) based on CT Angio at 12 months visit .The primary safety endpoint is defined as the proportion 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. The rate of stents with successful introduction and deployment of the iCover (iVascular) implanted as bridging stent in FEVAR. 2. The rate of stents without binary restenosis > 50% or occlusion on duplex scan and/or angioCTscan examination, or angiography at first postoperative imaging and at 6 months visits and at 12 months visit. 3. The 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. 4. The 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.5. The rate of stents without type I or III endoleaks postprocedure on duplex scan, angio CTscan or angiography discharge period, 6 months visit and at 12 months visit. 6. The rate of post-procedure mortality (all causes) within 30- day post procedure. 7. The rate of In-hospital post-procedure mortality (all causes). 8. The rate of endografts without aortic migration > 10 mm at 6 Months visit and 12 months visit. 9. The 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 months visit and 12 months visit. 10. Absence of post-procedural aortic surgical conversion between the implantation and the follow-up visits 11. Absence of aneurysm-related mortality post-procedure between the implantation and the follow-up visits. 12. Absence of aneurysm related secondary endovascular procedures between the implantation and the follow-up visits. 13. Aortic rupture, aneurysm-related death, in-hospital death, decline in ren | — |
Countries
Belgium, France, Germany, Netherlands, Spain
Contacts
Public ContactValentina Galimberti
1MED SA
Outcome results
None listed