NCT07529275

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: iVascular S.L.U. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Complex Abdominal Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-02-16
• Primary completion: 2028-06-30
• Completion: 2028-09-30
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

24 sites across 5 countries: Belgium, France, Germany, Netherlands, Spain