EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn

Launched by INTRESSA VASCULAR SA · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial, called the EXtensive MulTilayer StEnt TreatmeNt in Aortic DisSectiOn, is looking at a new treatment option for patients with Type B aortic dissection, which is a serious condition where the inner layer of the aorta tears. The study is testing the effectiveness and safety of a device called the Allay® Aortic Stent, which is used alongside standard endovascular treatment to help improve patient outcomes. The trial is currently recruiting participants aged 65 to 74 who have a type B aortic dissection that extends to certain areas of the body and who qualify for traditional treatment with stent grafts.

To be eligible for the trial, participants must have had symptoms of aortic dissection and need to be treated with a commercially available stent graft within 90 days of their symptoms starting. However, there are several factors that could exclude someone from participating, including age under 18, pregnancy, certain serious medical conditions, and specific anatomical issues with the aorta. If someone joins the study, they can expect to receive the Allay® Aortic Stent along with regular treatment and will be monitored for safety and effectiveness. It’s important to discuss any questions or concerns with a healthcare provider to determine if this trial is a good fit for individual circumstances.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a type B aortic dissection extending to the celiac trunk or beyond
• • Are eligible for thoracic endovascular treatment with stent grafts as per local guidelines, and physician's decision
• • Have been elected for treatment with commercially available stent graft as per their IFU within 90 days of dissection symptoms onset
• Exclusion Criteria:
• * General Exclusion Criteria:
• • Age \< 18 years
• • Pregnant, breast-feeding or planning on becoming pregnant during the entire duration of the study
• • Unable to provide written informed consent
• • Unable or unwilling to comply with the requirements of the study protocol
• • Taking part already in an investigational device or drug study that could interfere with the outcomes being studied
• • Active drug addiction or known history of drug abuse within one year of treatment
• * Medical Exclusion Criteria:
• • Aortic rupture, free or contained including haemothorax, increasing periaortic hematoma, or mediastinal hematoma
• • Aortic fistula
• • Suspicion of bowel necrosis or irreversible visceral ischemia
• • Stage 5 chronic kidney disease
• • Life expectancy of less than 2 years due to any other medical condition than the dissection to be treated
• • Active malignancy
• • Known sensitivities or allergies to the device materials (including cobalt, chromium, nickel)
• • Known sensitivities or allergies to contrast materials that cannot be pre-medicated
• • Mycotic aortic aneurysm or active systemic infection that may place the patient at increased risk of endovascular infection
• • American Society of Anaesthesiologists (ASA) class V (moribund patient not expected to live 24 hours with or without operation)
• • Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's, Loeys-Dietz or Ehlers-Danlos syndrome)
• • Uncorrectable coagulopathy, bleeding diathesis or refusal of blood transfusion
• • Any major cardiovascular or cerebrovascular ischemic event, including myocardial infarction or stroke, or treatment of such event, within 90 days prior to enrolment
• • Any aortic-related interventional or surgical procedure within 30 days prior to enrolment
• • Any planned aortic-related interventional or surgical procedure within 30 days after the study procedure
• * Anatomical Exclusion Criteria:
• • Aneurysmal dilatation of the false lumen defined as maximum transaortic diameter \>55 mm in women or \>60 mm in men in the thoraco-abdominal segment or \>50 mm in women or \>55 mm in men in the abdominal segment, measured inner-wall to inner-wall;
• • Inadequate proximal landing zone for the stent graft, such zone being \<20 mm long
• • Inadequate proximal landing zone geometry for the Allay® Aortic Stent (e.g. aortic kink)
• • Planned implantation of a stent graft with a distal diameter \>38 mm or \<20 mm
• • Aorta or iliac anatomy not allowing the advancement of the delivery system
• • Subject in whom the thoracic stent graft is either 1) not implanted in its intended position and/or 2) leads to any serious device complication, and/or who has 3) persistent static obstruction of the visceral or both renal arteries, prior to Allay® Aortic Stent implantation, will not be implanted with the Allay® Aortic Stent and will be withdrawn from the study