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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
RECRUITING
Houston
Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
RECRUITING
Houston
Contact Information
Primary
Harleen K Sandhu, MD, MPH
Harleen.K.Sandhu@uth.tmc.edu
7134865131
Backup
Kristofer M Charlton-Ouw, MD, FACS
Kristofer.CharltonOuw@uth.tmc.edu
713-486-5100
Time Frame
Start Date: 2018-10-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 436
Treatments
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)
Authors
Ali Azizzadeh
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston

This content was sourced from clinicaltrials.gov