Recruiting

Endovascular Repair vs. Best Medical Therapy

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT02622542

Conditions

Distal Aortic Dissection

Dissection, Aortic Acute

Acute Type B Aortic Dissection (Uncomplicated)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMT+TEVAR

BMT

Study Details

Brief 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.

Conditions

Distal Aortic Dissection

Dissection, Aortic Acute

Acute Type B Aortic Dissection (Uncomplicated)

Study ID

NCT02622542

Start date

Oct 1, 2018

Status verified date

Jan, 2022

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

436 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: BMT Alone

Patients in this group will be managed with the best medical therapy (BMT) alone

experimental: BMT+TEVAR

Patients in this group will be managed with thoracic endovascular aortic repair (TEVAR) in addition to the best medical therapy (BMT)

Interventions

BMT+TEVAR

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)

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.

Primary outcome measure

  • All-cause mortality [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Harleen K Sandhu, MD, MPH

7134865131Harleen.K.Sandhu@uth.tmc.edu

Kristofer M Charlton-Ouw, MD, FACS

713-486-5100Kristofer.CharltonOuw@uth.tmc.edu

Locations

Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Harleen K Sandhu, MD, MPH

713-486-5100harleen.k.sandhu@uth.tmc.edu

Kristofer M Charlton-Ouw, MD

713-486-5100Kristofer.CharltonOuw@uth.tmc.edu

Principal Investigator:

Harleen K Sandhu, MD, MPH

Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast

Recruiting

Houston, Texas, United States, 77089

Contacts

Gordon Martin, MD

713-486-1160

Naveed Saqib, MD

713-486-1160

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jan 27, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2022-01-27.