Actively Recruiting
A Clinical Study to Evaluate the Effectiveness and Safety of the Allay4 Aortic Stent as Adjunctive Endovascular Treatment of Type B Aortic Dissection in Patients Eligible for Thoracic Endovascular Repair With Stent Grafts
Led by Intressa Vascular SA · Updated on 2025-05-18
72
Participants Needed
10
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of the Allay4 Aortic Stent as an additional endovascular treatment for patients with Type B aortic dissection who are eligible for thoracic endovascular aortic repair using stent grafts. The study focuses on reducing late complications such as aortic growth requiring reintervention or rupture. It is a prospective, multicenter, open-label clinical trial designed to assess this investigational device alongside standard care. The treatment involves first placing a covered thoracic stent graft in the descending thoracic aorta above the celiac trunk, following standard care procedures. Subsequently, the Allay4 Aortic Stent is implanted from within the stent graft and extends below the celiac trunk to the end of the dissected aorta, usually reaching the aortoiliac bifurcation. This combined approach aims to improve outcomes for patients undergoing thoracic endovascular repair. Participants will undergo assessments including imaging by CT scans at various time points up to 60 months to evaluate aortic growth, device performance, and adverse events. Researchers will monitor freedom from aortic growth requiring reintervention or rupture at 12 months as the primary outcome, along with major adverse events within 30 days post-implantation. Long-term follow-up visits will assess mortality, reintervention, device patency, and complications, with participant involvement lasting several years for comprehensive safety and effectiveness monitoring.
CONDITIONS
Brief Title
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 within 90 days of dissection symptoms onset
You will not qualify if you...
- Age under 18 years
- Pregnant, breast-feeding, or planning pregnancy during the study
- Unable to provide written informed consent
- Unable or unwilling to comply with study protocol
- Currently in another investigational device or drug study interfering with outcomes
- Active drug addiction or history of drug abuse within one year
- Aortic rupture, periaortic or mediastinal hematoma
- Aortic fistula
- Suspected bowel necrosis or irreversible visceral ischemia
- Stage 5 chronic kidney disease
- Life expectancy less than 2 years due to other conditions
- Active malignancy
- Allergies to device materials or contrast not pre-medicated
- Mycotic aortic aneurysm or active systemic infection
- ASA class V (moribund patient)
- Diagnosed or suspected connective tissue diseases (e.g., Marfan's)
- Uncorrectable bleeding disorders or refusal of blood transfusion
- Major cardiovascular or cerebrovascular events within 90 days
- Aortic-related surgeries within 30 days before or planned within 30 days after study
- Aneurysmal dilatation exceeding specified diameter limits
- Inadequate proximal landing zone or geometry for stent graft or Allay4 Aortic Stent
- Planned stent graft with distal diameter outside 20-38 mm
- Aorta or iliac anatomy preventing device advancement
- Thoracic stent graft not implanted as intended or causing serious complications
- Persistent obstruction of visceral or renal arteries before Allay4 implantation resulting in withdrawal from study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 90 days from dissection symptom onset
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At the time of the index procedure
Participants undergo thoracic endovascular aortic repair (TEVAR) with stent grafts followed by implantation of the Allay® Aortic Stent as adjunctive treatment of type B aortic dissection.
1 procedure visit (in-person)
Duration - Up to 60 months
Participants are monitored for safety and effectiveness outcomes including adverse events and device performance through imaging and clinical assessments.
Follow-up visits at discharge, 30 days, and at 12, 24, 36, 48, and 60 months
Trial Site Locations
Total: 10 locations
1
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Not Yet Recruiting
2
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
3
CHU Liège
Liège, Belgium, 4000
Actively Recruiting
4
Acibadem City Clinic University Hospital and Cardiovascular Center
Sofia, Bulgaria, 1407
Not Yet Recruiting
5
Hopital Européen Georges Pompidou AP-HP
Paris, France, 75015
Not Yet Recruiting
6
Universitätsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Actively Recruiting
7
Universitätsklinikum Leipzig AöR
Leipzig, Germany, 04103
Actively Recruiting
8
University Hospital of Münster
Münster, Germany, 48149
Not Yet Recruiting
9
University Clinical Centre of Serbia
Belgrade, Serbia, 11000
Not Yet Recruiting
10
Republican Research Centre of Emergency Medicine
Tashkent, Uzbekistan, 100107
Actively Recruiting
Research Team
V
Virginie Martin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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