EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn

NCT06675617 | Recruiting

• 1 other identifier: CP-P3-03-001
• Study Type: interventional
• Target: 72
• Locations: 6 countries
• Sites: 10

Brief Summary

This clinical trial is a prospective, multicenter, open label study designed to evaluate the effectiveness and the safety of the Allay® Aortic Stent as adjunctive endovascular treatment of Type B aortic dissection in patients eligible for thoracic endovascular aortic repair with stent grafts.

Conditions

Type B Aortic Dissection

Keywords

TBAD; Allay; aortic; dissection; type B

Outcome Measures

Primary Outcomes (1)

• Freedom from aortic growth requiring secondary reintervention, including open conversion, or aortic rupture in the region treated by the Allay® Aortic Stent at 12 months

  An aortic growth requiring reintervention in the region treated with the Allay® Aortic Stent is defined as an increase in maximum aortic transverse diameter \>10mm at 12 months relative to the first post-operative CT scan done at discharge and not later than 30 days.

  12 months

Secondary Outcomes (22)

• Percentage of Participants with Successful Technical Performance of the Allay® Aortic Stent Implantation

  At index procedure

• Incidence of Major Adverse Events (MAE) within 30 Days After Allay® Aortic Stent Implantation

  30 days

• Freedom from all-cause mortality;

  Immediately at discharge and subsequent follow-up visits, at 30 days, 12, 24, 36, 48 and 60 months

• Freedom from Dissection-Related Mortality

  Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.

• Freedom from Readmission (Post-Discharge)

  Subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.

Study Arms (1)

Allay Aortic Stent

EXPERIMENTAL

A covered thoracic stent graft is first deployed in supraceliac position as per standard of care then followed by the implantation of the Allay® Aortic Stent deployed from within the stent graft, extending below the celiac trunk to the end of the dissected aorta, typically the aortoiliac bifurcation.

Device: Allay Aortic Stent

Interventions

Allay Aortic Stent DEVICE

Endovascular treatment of an aortic dissection

Allay Aortic Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Intressa Vascular SA: lead

Study Sites (10)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

CHU Liège

Liège, 4000, Belgium

RECRUITING

Acibadem City Clinic University Hospital and Cardiovascular Center

Sofia, 1407, Bulgaria

NOT YET RECRUITING

Hopital Européen Georges Pompidou AP-HP

Paris, 75015, France

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

Universitätsklinikum Leipzig AöR

Leipzig, 04103, Germany

RECRUITING

University Hospital of Münster

Münster, 48149, Germany

NOT YET RECRUITING

University Clinical Centre of Serbia

Belgrade, 11000, Serbia

NOT YET RECRUITING

Republican Research Centre of Emergency Medicine

Tashkent, 100107, Uzbekistan

RECRUITING

Study Officials

• Wolf-Hans Eilenberg, MD, PhD, FEBVS

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie Martin

CONTACT

+3281 71 99 41; virginie.martin@intressavascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 5, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2031
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

BU (1); FR (1); SE (1); UZ (1); BE (3); DE (3)