acute uncomplicated type B aortic dissection
Conditions
Interventions
The endovascular procedure will be performed in either an operating room or
catheterization laboratory with angiographic guidance to facilitate device
placement. The exact type of anesthesia adminis
Sponsors
W.L Gore and Associates, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Presence of acute uncomplicated type B dissection acute defined as time from symptom onset to teratment 2.0 cm - proximal landing zone diameters between 23-42 mm - non tortuous or non stenotic iliac and or femoral arteries and ability to use a conduit for vascular access. 4. able to tolerate endotracheal intubation and general anesthesia 5. age 18 to 80 years 6. declaration of voluntary participation in the study with signed informed consent form. 7. capable of complying with study protocol requirements, including long term medical treatment with beta blockers, diuretics and or ace inhibitors and follow-up for 3 years post treatment.
Exclusion criteria
Exclusion criteria: Exclusion criteria;1. ASA classification V 2. severe renal insufficiency defined as SVS risk renal status=3 3. severe respiratory insufficiency defined as SVS risk pulmonary status=3 4. presence of connective tissue disease (Marfan, Ehlers-Danlos) 5. active infection of active vasculitides 6. positive pregnancy test 7. participation in another medical research study within 3 months prior of study enrollment 8. myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment 9. planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrollment 10. history of drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters/outcome of the study: The primary endpoint for this study is a composite of the following events: Incomplete/no false lumen thrombosis at, aortic dilatation at, or aortic rupture through the 1-year follow-up visit. · Incomplete & Complete Thrombosis · Test Group: Incomplete thrombosis will be defined as the presence of blood flow in any portion of the false lumen parallel to the stent graft, excluding the distal 2 cm; Complete thrombosis will be defined as absence of blood flow in any portion of the false lumen parallel to the stent graft, excluding the distal 2 cm.; No false lumen thrombosis will be defined as the presence of blood flow throughout the entire false lumen within the descending thoracic aorta parallel to the stent graft. Control Group: Incomplete thrombosis will be defined as the presence of blood flow in any portion of the false lumen at any point in the descending thoracic aorta. Complete thrombosis will be defined as absence of blood flow in any portion of the false lumen at any point in the descending thoracic aorta. No false lumen thrombosis will be defined as the presence of blood flow throughout the entire false lumen within the descending thoracic aorta. · Aortic dilatation will be defined as an increase of *5 mm in the maximum diameter of the descending thoracic aorta compared to the pre-treatment CT measurement or the maximum diameter of the descending thoracic aorta *55 mm at the 1-year follow-up visit · Aortic rupture will be defined as disruption of the thoracic aorta with fresh blood outside the adventitia observed on CT, radiograph, or other radiologic modalities at any time through the 1-year follow-up visit All randomized patients will be evaluated on an Intent-To-Treat basis. Per protocol and sensitivity analyses will also be performed. Treatment crossover before intervention will not be permitted | — |
Secondary
| Measure | Time frame |
|---|---|
| Many variables will be collected during this trial. These will include, but are not limited to, the following: * Pre-treatment data o Demographics, co-morbidities, aortic morphology * Treatment data o Access success failure o Procedure time o Quantity and size of stents (Test group only) o Adjunctive procedures o Incidence of adverse events and device events * Follow-up data o Type and dosage of hypertension medication o Hospital and intensive care unit stay o Aortic morphology post-treatment including false lumen thrombosis and true and false lumen diameters o Incidence of adverse events and device events o Mortality (all-cause and dissection-related) Of special interest in this patient population is the incidence of dissection-related mortality. Dissection-related mortality will be collected during the study and will be defined as death a) within 30 days of initial treatment, b) before hospital discharge, c) within 30 days of a secondary endovascular or surgical intervention, or d) directly caused by the aortic dissection. | — |
Countries
Netherlands
Outcome results
None listed