Intressa Vascular announces the start of the EXTENSO clinical study

Gembloux, Belgium, June 2, 2025 – Intressa Vascular SA, a clinical-stage MedTech company, today announces the first patient enrolment in the EXTENSO clinical study (NCT06675617). This study will evaluate the 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 is a life-threatening cardiovascular condition with poor clinical outcome. Current treatment options are suboptimal, especially when the dissection extends to areas of the aorta where vessels feeding organs and limbs branch off from the aorta: as per the impermeable nature of stent grafts, their use is limited to a part of the aorta, leaving the rest untreated and the patient at risk of future reoperation. The goal of the study is to evaluate the use of the Allay® Aortic Stent in combination with such stent graft, to treat the aortic dissection extensively, reduce the growth of the aorta and therefore the need for late reoperation.

We are proud to announce that the first patient is now enrolled in EXTENSO and has been successfully treated with a combination of a thoracic stent graft and the Allay® Aortic Stent. The study is currently open for enrolment in Belgium, Germany and Uzbekistan, with additional regulatory submissions ongoing in a series of other European countries. As of today, 27 investigators/centers have confirmed their interest in participating in the study.

“The concept of distal extension to a stent graft to treat patients when their dissection extends far into the abdominal aorta is a valuable option; it’s now years we are searching for the appropriate device to provide better scaffolding of the distal dissected aorta, stabilizing the true lumen, hopefully better remodeling without any risk of side branch occlusion! I am thrilled to see this being evaluated in the EXTENSO study”, states Professor Christoph Nienaber, from Royal Brompton Hospital, NHS Trust, London, Chair of the Study Steering Committee.

“It is exciting to see the first patient enrolled in the EXTENSO study. We need new options to provide our patients with aortic dissection with extensive treatment and reduce the risk of reinterventions. The Allay® Aortic Stent bears the potential to be such a solution” shares Associate Professor Wolf-Hans Eilenberg MD, PhD, FEBVS from Medical University of Vienna, Coordinating Investigator of the EXTENSO study.

“This first patient enrolled in the EXTENSO clinical study is a major milestone in the company’s clinical development and product registration activities which are supported by our investors” tells Pierre Douette, Intressa Vascular’s CEO. “Patients with aortic dissection deserve better treatment options than what they are proposed today, so they no longer have to fear future reinterventions. We are thrilled by the start of the EXTENSO study, which evaluates the potential of the Allay® Aortic Stent to be such an option for patients and physicians”, adds Eric Boulogne, VP Clinical Affairs at Intressa Vascular.