Treatment for Type B Aortic Dissection using Allay Aortic Stent

A Clinical Study to Evaluate the Effectiveness and Safety of the Allay® Aortic Stent as Adjunctive Endovascular Treatment of Type B Aortic Dissection in Patients Eligible for Thoracic Endovascular Repair With Stent Grafts

This study is testing if adding the Allay® Aortic Stent to standard treatment can help people with Type B aortic dissection avoid serious complications and aortic growth.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Intressa Vascular SA (industry)
• Locations: 10 sites (Genk and 9 other locations)
• Trial ID: NCT06675617 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of the Allay® Aortic Stent as an adjunctive treatment for Type B aortic dissection in patients eligible for thoracic endovascular aortic repair (TEVAR). The study involves the placement of a CE-marked Thoracic Stent Graft followed by the implantation of the Allay® Aortic Stent to reduce the risk of aortic growth and complications. It aims to demonstrate a low rate of aortic growth requiring secondary interventions or rupture within 12 months, while also assessing major adverse events within 30 days post-implantation.

Who should consider this trial

Good fit: Ideal candidates are adults with Type B aortic dissection extending to the celiac trunk who are eligible for thoracic endovascular treatment.

Not a fit: Patients with aortic rupture or those under 18 years old will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of complications associated with Type B aortic dissection.

How similar studies have performed: Other studies have shown success with similar endovascular approaches, suggesting potential for positive outcomes in this trial.

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

Where this trial is running

Genk and 9 other locations

• Ziekenhuis Oost-Limburg — Genk, Belgium (NOT_YET_RECRUITING)
• UZ Leuven — Leuven, Belgium (NOT_YET_RECRUITING)
• CHU Liège — Liège, Belgium (RECRUITING)
• Acibadem City Clinic University Hospital and Cardiovascular Center — Sofia, Bulgaria (NOT_YET_RECRUITING)
• Hopital Européen Georges Pompidou AP-HP — Paris, France (NOT_YET_RECRUITING)
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany (RECRUITING)
• Universitätsklinikum Leipzig AöR — Leipzig, Germany (RECRUITING)
• University Hospital of Münster — Münster, Germany (NOT_YET_RECRUITING)
• University Clinical Centre of Serbia — Belgrade, Serbia (NOT_YET_RECRUITING)
• Republican Research Centre of Emergency Medicine — Tashkent, Uzbekistan (RECRUITING)

Study contacts

• Principal investigator: Wolf-Hans Eilenberg, MD, PhD, FEBVS — Medical University of Vienna
• Study coordinator: Virginie Martin

Conditions: Type B Aortic Dissection, TBAD, Allay, aortic, dissection, type B