ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
A Randomized Controlled Comparative Study on Effectiveness of Endovascular Repair Versus Best Medical Therapy for Acute Uncomplicated Type B Aortic Dissection
The University of Texas Health Science Center, Houston
436 participants
Oct 1, 2018
INTERVENTIONAL
Conditions
Summary
The purpose of the study is to conduct a randomized controlled trial comparing best medical therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for uncomplicated acute type B aortic dissection.
Eligibility
Inclusion Criteria6
- Aged ≥18 years, regardless of race or ethnicity;
- Diagnosed with uncomplicated ABAD, i.e., a primary entry tear distal to left subclavian artery with no evidence of malperfusion, end-organ ischemia, rupture, or intractable pain, and onset of symptoms is ≤30 days prior to enrollment;
- Patient has been stabilized after the acute event with control of pain and blood pressure using ≤3 intravenous antihypertensive medications;
- Adequate imaging, e.g., CT with contrast (chest + abdomen+ pelvis) is available prior to enrollment; and
- Indicates willingness to comply with the study protocol and is able to provide a written informed consent;
- Meets criteria for inclusion in the National Death Index and Social Security Death Master File.
Exclusion Criteria19
- Diagnosed with Type A aortic dissection;
- Evidence of complicated ABAD;
- Chronic Type B aortic dissection (\>6 weeks from onset of symptoms);
- Unable to be randomized and undergo treatment according to protocol within 30 days of symptom onset;
- Diagnosed with traumatic dissection or penetrating ulcer;
- Anatomy is not suitable for TEVAR;
- Previous descending thoracic or abdominal aortic surgery (open or endovascular);
- Unsuitable access sites, including infection at access sites;
- Associated aortic aneurysm (descending aortic diameter ≥5.0 cm);
- Life expectancy \<2 years;
- Unable or unlikely to comply with BMT;
- Unable or refuse to comply with follow-up;
- Intend to participate in another trial within 3 months of enrollment;
- Pregnant or breast-feeding;
- Vasculitis or known genetic connective tissue disorder (Marfan's syndrome or Ehlers-Danlos syndrome)
- Active systemic infection;
- Chronic kidney disease stage 3-5 (estimated glomerular filtration rate \<60 mL/min/1.73m2);
- Cerebral vascular accident within past 3 months; or
- Clinically significant gastrointestinal bleeding, major surgery, myocardial infarction, or untreated coagulopathy within past 6 weeks.
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Interventions
These FDA-approved devices will be used for performing TEVAR in the patients randomized to this arm, in addition to the medical therapy to control blood pressure (BMT)
Optimal medical therapy will be administered to the patients randomized to this arm, involving but not limited to, beta-blockers, etc., to control the blood pressure and pain for stabilizing the patient upon presentation.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02622542