ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Dec 3, 2015

Keywords

ClinConnect Summary

This clinical trial is studying the best ways to treat a specific condition called uncomplicated acute type B aortic dissection, which is a tear in the aorta (the large blood vessel that carries blood from the heart) that needs immediate attention but is not life-threatening. Researchers want to compare two treatment approaches: one group will receive the best medical therapy (BMT) alone, while the other group will receive BMT along with a procedure called thoracic endovascular aortic repair (TEVAR). This study aims to find out which approach is more effective in helping patients recover.

To participate in this trial, individuals need to be at least 18 years old and diagnosed with uncomplicated acute type B aortic dissection within the last 30 days. They should have their pain and blood pressure under control and be able to provide consent for the study. Participants will be randomly assigned to one of the two treatment groups and will receive regular follow-up care throughout the trial. It's important for potential participants to know that certain conditions or previous surgeries may exclude them from joining the study. This research will help improve treatment options for future patients with this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.