Intressa Vascular announces the first patient enrolment in the EXTENSO clinical study in Germany

Gembloux, Belgium, September 25, 2025 – Intressa Vascular SA, a clinical-stage MedTech company, today announces the first patient enrolment in the EXTENSO clinical study (NCT06675617) in Germany. This study evaluates the innovative multilayer Allay® Aortic Stent as distal extension to stent graft in patients with TBAD eligible for thoracic endovascular repair with stent grafts and their dissection extending to the celiac trunk or beyond.

Aortic dissection remains a severe cardiovascular emergency with high morbidity and mortality. Current therapies have important limitations, particularly when the dissection extends into segments of the aorta supplying vital organs and extremities. The impermeable design of standard stent grafts restricts their applicability, leaving portions of the diseased aorta untreated and patients at risk of subsequent surgical procedures. This clinical study aims to investigate whether the Allay® Aortic Stent, when used alongside a conventional stent graft, can provide a more extensive repair, limit aortic growth, and decreasing the long-term need for reintervention.

We are proud to announce that the first patient is now enrolled in EXTENSO in Germany and has been successfully treated with a combination of a thoracic stent graft and the Allay® Aortic Stent. The study is also enrolling in Uzbekistan and in Belgium, while more interested investigators/centers are expected to open in the coming weeks as regulatory approvals are obtained in other European countries.

“Each new patient in the EXTENSO study brings the concept of distal extension to a stent graft closer to reality. This trial will bring confirmatory data about the adjunctive use of the Allay® Aortic stent in these patients eligible to conventional stent graft with their aortic dissection extending into the abdominal aorta. I am delighted to see the study advancing with the first patient enrolled in a German center”, states Professor Christoph Nienaber, from Royal Brompton Hospital, NHS Trust, London, Chair of the Study Steering Committee.

“Being the first to enroll and treat a patient in Europe with the Allay® Aortic Stent as part of the EXTENSO study is both an honor and an exciting milestone. As physicians, we are driven by innovation that can truly change the standard of care of this life-threatening cardiovascular condition, and this study represents an important step in that direction”, indicates Professor Andrej Schmidt, MD, Senior Interventionalist at University of Leipzig Medical Center.

“With this first EXTENSO patient in Germany, we reaffirm our commitment to providing a better treatment option for physicians and patients with aortic dissection”, tells Pierre Douette, Intressa Vascular CEO. “We are excited to start the EXTENSO study in Europe and continue supporting the (future) investigators in evaluating the potential of the Allay® Aortic Stent in this underserved disease”, adds Eric Boulogne, VP Clinical Affairs at Intressa Vascular.