Actively Recruiting
ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
Led by The University of Texas Health Science Center, Houston · Updated on 2022-01-27
436
Participants Needed
2
Research Sites
400 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with uncomplicated acute type B aortic dissection with primary tear distal to left subclavian artery
- No evidence of malperfusion, end-organ ischemia, rupture, or intractable pain
- Onset of symptoms within 30 days prior to enrollment
- Stabilized with control of pain and blood pressure using three or fewer intravenous antihypertensive medications
- Adequate imaging (CT with contrast including chest, abdomen, pelvis) available before enrollment
- Willingness to comply with study protocol and ability to provide written informed consent
- Meets criteria for inclusion in National Death Index and Social Security Death Master File
You will not qualify if you...
- Diagnosed with Type A aortic dissection
- Evidence of complicated acute type B aortic dissection
- Chronic Type B dissection (symptoms onset more than 6 weeks prior)
- Cannot be randomized or treated within 30 days of symptom onset
- Diagnosed with traumatic dissection or penetrating ulcer
- Anatomy unsuitable for TEVAR
- Previous descending thoracic or abdominal aortic surgery
- Unsuitable or infected access sites
- Associated aortic aneurysm with descending aortic diameter 5.0 cm or greater
- Life expectancy less than 2 years
- Unable or unwilling to comply with best medical therapy
- Unable or unwilling to comply with follow-up
- Planning to participate in another trial within 3 months
- Pregnant or breastfeeding
- Vasculitis or known genetic connective tissue disorder (Marfan's or Ehlers-Danlos syndrome)
- Active systemic infection
- Chronic kidney disease stage 3-5 (eGFR less than 60 mL/min/1.73m2)
- Cerebral vascular accident within last 3 months
- Significant gastrointestinal bleeding, major surgery, myocardial infarction, or untreated coagulopathy within last 6 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
2
Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
Houston, Texas, United States, 77089
Actively Recruiting
Research Team
H
Harleen K Sandhu, MD, MPH
CONTACT
K
Kristofer M Charlton-Ouw, MD, FACS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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