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February 24, 2026
iVascular Begins FENCO Study of iCover Stent in FEVAR
KEY TAKEAWAYS
- Enrollment has begun in the FENCO study evaluating iVascular’s iCover balloon-expandable ePTFE-covered stent system in FEVAR.
- The European prospective, multicenter, single-arm study plans to enroll up to 165 patients at 24 centers across five countries.
- Coprimary endpoints are 12-month bridging stent patency and absence of target vessel instability at 12 months.
February 24, 2026—iVascular announced the enrollment of the first patient in the FENCO clinical study evaluating the company’s iCover balloon-expandable polytetrafluoroethylene (ePTFE)–covered stent system in fenestrated endovascular aneurysm repair (FEVAR) for the treatment of complex abdominal aortic aneurysms.
According to the company, the FENCO study is designed to assess the performance and safety of the iCover ePTFE-covered device when used as a bridging stent graft in complex aortic anatomies. The prospective, single-arm, European multicenter study will enroll up to 165 patients across 24 centers in five countries during a 12-month period.
The iVascular press release stated that the trial’s coprimary endpoints are bridging stent patency—defined as the absence of binary restenosis at 12 months—and the absence of target vessel instability from implantation through the 12-month follow-up.
The first patient was enrolled at the Centre Hospitalier Universitaire de Bordeaux in Bordeaux, France, by a team led by Professor Eric Ducasse, MD, together with Professor Vincent Riambau, MD, of Hospital Clínic de Barcelona in Barcelona, Spain.
Professors Ducasse and Riambau commented on the initiation of the trial in the company’s press release.
“We are proud to be participating in the FENCO trial and to have successfully enrolled our first patient,” stated Prof. Ducasse, who is Principal Investigator of the study. “This milestone reflects our ongoing commitment to improving outcomes for our patients. We expect all sites to start their recruitment in the upcoming months.”
Prof. Riambau added, “The initiation of the FENCO trial represents a key step toward generating robust clinical evidence on the use of FEVAR with iCover in patients with complex aortic aneurysms.”
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