Type B Aortic Dissection
Conditions
Keywords
type b dissection, thoracic stentgraft, aortic stent, clinical and technical success, safety and feasibility of E-XL aortic stent
Brief summary
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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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 |
Countries
Germany, Italy, Poland, Spain