iVascular has announced the enrolment of the first patient in the fenCo clinical study, marking the initiation of a European clinical trial evaluating iCover in fenestrated endovascular aneurysm repair (FEVAR) for the treatment of complex abdominal aortic aneurysms. The study is designed to assess the performance and safety of the iCover balloon-expandable, ePTFE-covered stent when used as a bridging stent graft in complex aortic anatomies.
FenCo is a prospective, single-arm, European multicentre study that will enrol up to 165 patients across 24 centres in five countries over a 12-month enrolment period. The trial’s co-primary 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 (Bordeaux, France) by a team led by Eric Ducasse, principal investigator together with Vincent Riambau (Hospital Clínic de Barcelona, Barcelona, Spain).
“We are proud to be participating in the fenCo trial and to have successfully enrolled our first patient,” said Ducasse. “This milestone reflects our ongoing commitment to improving outcomes for our patients. We expect all sites to start their recruitment in the upcoming months.”
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.”
iVascular highlights recent physician-initiated iCover studies in FEVAR that have reported high technical success rates (94–97.6%), “excellent” target vessel patency, and a favourable safety profile in complex aortic anatomies. The company expects the results of the fenCo study to further support the role of iCover as a bridging stent in FEVAR procedures.
