A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

Study Overview
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Brief Summary
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Cohort study according to national regulatory guidelines: Non-interventional, observational cohort study. Pair-matched comparison with patients chosen from historical series. To evaluate the clinical and technical success as well as the safety and feasibility of the E-XL aortic stent used in complicated type B aortic dissection in addition to a classic stentgraft in a single procedure.

Official Title
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ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

Conditions
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Type B Aortic Dissection

Participation Criteria
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Eligibility Criteria
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The clinical records of the patients mus support the following criteria: Age > 18 years Type B dissection with expanding false lumen eligible for endovascular treatment which occured within 90 days prior to implantation The endovascular treatment may be associated with a complementary surgical operation The total diameter of the dissected aortic segment should not surpass 6cm, and have increased between 0.5 and 1cm within 1 month, prior to implantation Visceral arteries involvement, i.e. perfusion of side branches via true or false lumen of type B dissection Aortic kinking < 90° The patient must be available for the appropriate follow-up times for the duration of the study Informed consent from patient or authorized relative The data of whose patients clinical records confirm one of the following conditions will not be considered in this study: Patients with a contraindication as indicated in the instruction for use Patients with chronic thrombocytopenia or ongoing anticoagulation Patients with renal failure and/or creatinine >2.4mg/dl immediately before the intervention Patients in whom the false lumen is completely thrombosed Patients with ongoing infection Patients with ongoing cancer Patients who are enrolled in a clinical study Aortic landing zone diameter over 40 mm Potentially emboligenic iliac and aortic atheroma lesions Associated pathology with life expectancy of less than 24 months Unstable infectious syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thoracic Stentgraft plus E-XL<br>male and female patients with complicated type B aortic dissection involving the infra-diaphragmatic aorta treated with any thoracic stentgraft extended by the E-XL aortic stent | |
| Control group<br>historical control group fulfilling the following criteria: Age +/- 3 years Sex matched Same follow-up period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical and technical success as well as the safety and feasibility of the E-XL aortic stent used in complicated type B aortic dissection in addition to a classic thoracic stent-graft in a single procedure. |  | February 2014 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type b dissection, thoracic stentgraft, aortic stent, clinical and technical success, safety and feasibility of E-XL aortic stent