Actively Recruiting
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
Led by Intressa Vascular SA · Updated on 2025-05-18
72
Participants Needed
10
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 chosen for treatment with a commercially available stent graft within 90 days of dissection symptoms starting
You will not qualify if you...
- Age under 18 years
- Pregnant, breastfeeding, or planning pregnancy during the study
- Unable to provide written informed consent
- Unable or unwilling to follow the study protocol
- Currently participating in another investigational device or drug study that could affect results
- Active drug addiction or drug abuse within one year
- Aortic rupture or related serious complications
- Aortic fistula
- Suspicion of bowel necrosis or irreversible visceral ischemia
- Stage 5 chronic kidney disease
- Life expectancy less than 2 years due to conditions other than dissection
- Active cancer
- Allergies to device materials or contrast agents that cannot be treated
- Mycotic aortic aneurysm or active systemic infection increasing risk
- ASA class V (moribund patient unlikely to survive 24 hours)
- Diagnosed or suspected connective tissue diseases like Marfan's, Loeys-Dietz, or Ehlers-Danlos syndrome
- Uncorrectable bleeding disorders or refusal of blood transfusion
- Major cardiovascular or cerebrovascular ischemic events within 90 days
- Aortic-related procedures within 30 days before or planned within 30 days after study procedure
- Aneurysmal dilation exceeding defined size limits
- Inadequate anatomical conditions for stent graft or Allay4 Aortic Stent implantation
- Serious device complications or persistent obstruction before Allay4 Aortic Stent implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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