RECRUITING

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

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Conditions

Distal Aortic DissectionDissection, Aortic AcuteAcute Type B Aortic Dissection (Uncomplicated)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-10-01
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02622542

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged ≥18 years, regardless of race or ethnicity;
  2. * 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;
  3. * Patient has been stabilized after the acute event with control of pain and blood pressure using ≤3 intravenous antihypertensive medications;
  4. * Adequate imaging, e.g., CT with contrast (chest + abdomen+ pelvis) is available prior to enrollment; and
  5. * Indicates willingness to comply with the study protocol and is able to provide a written informed consent;
  6. * Meets criteria for inclusion in the National Death Index and Social Security Death Master File.
  1. * Diagnosed with Type A aortic dissection;
  2. * Evidence of complicated ABAD;
  3. * Chronic Type B aortic dissection (\>6 weeks from onset of symptoms);
  4. * Unable to be randomized and undergo treatment according to protocol within 30 days of symptom onset;
  5. * Diagnosed with traumatic dissection or penetrating ulcer;
  6. * Anatomy is not suitable for TEVAR;
  7. * Previous descending thoracic or abdominal aortic surgery (open or endovascular);
  8. * Unsuitable access sites, including infection at access sites;
  9. * Associated aortic aneurysm (descending aortic diameter ≥5.0 cm);
  10. * Life expectancy \<2 years;
  11. * Unable or unlikely to comply with BMT;
  12. * Unable or refuse to comply with follow-up;
  13. * Intend to participate in another trial within 3 months of enrollment;
  14. * Pregnant or breast-feeding;
  15. * Vasculitis or known genetic connective tissue disorder (Marfan's syndrome or Ehlers-Danlos syndrome)
  16. * Active systemic infection;
  17. * Chronic kidney disease stage 3-5 (estimated glomerular filtration rate \<60 mL/min/1.73m2);
  18. * Cerebral vascular accident within past 3 months; or
  19. * Clinically significant gastrointestinal bleeding, major surgery, myocardial infarction, or untreated coagulopathy within past 6 weeks.

Contacts and Locations

Study Contact

Harleen K Sandhu, MD, MPH
CONTACT
7134865131
Harleen.K.Sandhu@uth.tmc.edu
Kristofer M Charlton-Ouw, MD, FACS
CONTACT
713-486-5100
Kristofer.CharltonOuw@uth.tmc.edu

Principal Investigator

Kristofer M Charlton-Ouw, MD, FACS
PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Study Locations (Sites)

Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
Houston, Texas, 77030
United States
Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
Houston, Texas, 77089
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Kristofer M Charlton-Ouw, MD, FACS, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-01
Study Completion Date2026-06

Study Record Updates

Study Start Date2018-10-01
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Distal Aortic Dissection
  • Dissection, Aortic Acute
  • Acute Type B Aortic Dissection (Uncomplicated)