Comparing endovascular repair to best medical therapy for acute type B aortic dissection

A Randomized Controlled Comparative Study on Effectiveness of Endovascular Repair Versus Best Medical Therapy for Acute Uncomplicated Type B Aortic Dissection

This study is testing whether adding a specific type of surgery to standard medical treatment can help people with a certain type of aortic dissection live longer and have a better quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 436 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT02622542 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of best medical therapy (BMT) alone versus BMT combined with thoracic endovascular aortic repair (BMT+TEVAR) in patients with uncomplicated acute type B aortic dissection. It is a prospective, randomized, controlled trial involving 436 adult participants who will be allocated to one of the two treatment arms. The study will assess all-cause mortality as the primary outcome, along with secondary outcomes related to major morbidity events and quality of life measures. The trial is expected to last approximately 10 years, with a 5-year follow-up for each patient.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with uncomplicated acute type B aortic dissection within 30 days of symptom onset.

Not a fit: Patients with Type A aortic dissection or those with evidence of complicated acute type B aortic dissection are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment approach for patients with uncomplicated acute type B aortic dissection, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have explored similar treatment approaches, but this specific comparison of BMT versus BMT+TEVAR in uncomplicated acute type B aortic dissection is relatively novel.

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.

Where this trial is running

Houston, Texas and 1 other locations

• Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center — Houston, Texas, United States (Recruiting)
• Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Kristofer M Charlton-Ouw, MD, FACS — University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
• Study coordinator: Harleen K Sandhu, MD, MPH

Conditions Distal Aortic Dissection; Dissection, Aortic Acute; Acute Type B Aortic Dissection