Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID02622542

Randomized Controlled Study Comparing Endovascular Repair Versus Best Medical Therapy for Acute Uncomplicated Type B Aortic Dissection

Led by The University of Texas Health Science Center, Houston · Updated on 2022-01-27

436

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of two treatment approaches for adults with uncomplicated acute type B aortic dissection, a condition where a tear occurs in the part of the aorta outside the heart. This prospective, randomized clinical trial compares best medical therapy (BMT) alone versus BMT combined with thoracic endovascular aortic repair (TEVAR). The study aims to determine differences in all-cause mortality and major health events over five years, helping to establish a standard treatment protocol for this condition. Participants will be randomly assigned to one of two groups: one receiving best medical therapy alone, which includes medications like beta-blockers to control blood pressure and pain, and the other receiving TEVAR using FDA-approved devices along with the same medical therapy. The study will enroll 436 adults, and follow-up will continue for five years after treatment to monitor outcomes. During the study, participants will undergo various assessments, including imaging tests like CT scans, to evaluate the aorta's condition. Researchers will track mortality rates, major complications such as rupture or organ failure, and quality of life measures. The study is conducted at a single center and includes long-term follow-up to gather comprehensive data on safety and health outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older, any race or ethnicity
  • Diagnosed with uncomplicated acute type B aortic dissection within 30 days prior to enrollment
  • Stabilized after the acute event with pain and blood pressure controlled using 3 or fewer intravenous antihypertensive medications
  • Adequate imaging such as contrast CT of chest, abdomen, and pelvis available before enrollment
  • Willing and able to comply with study protocol and provide written informed consent
  • Meets criteria for inclusion in National Death Index and Social Security Death Master File
Not Eligible

You will not qualify if you...

  • Diagnosed with type A aortic dissection
  • Evidence of complicated acute type B aortic dissection
  • Chronic type B aortic dissection longer than 6 weeks from symptom onset
  • Unable to be randomized and treated within 30 days of symptom onset
  • Diagnosed with traumatic dissection or penetrating ulcer
  • Anatomy unsuitable for thoracic endovascular aortic repair
  • Previous descending thoracic or abdominal aortic surgery
  • Unsuitable or infected access sites
  • Associated aortic aneurysm with diameter 5.0 cm or larger
  • Life expectancy less than 2 years
  • Unable or unwilling to comply with best medical therapy or follow-up
  • Participation in another trial within 3 months prior to enrollment
  • Pregnant or breast-feeding
  • Vasculitis or known genetic connective tissue disorders such as Marfan's or Ehlers-Danlos syndrome
  • Active systemic infection
  • Chronic kidney disease stage 3 to 5 with low kidney function
  • Stroke within past 3 months
  • Significant gastrointestinal bleeding, major surgery, heart attack, or untreated blood clotting disorder within past 6 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 30 days from symptom onset for treatment initiation; medical therapy and device intervention as per protocol

Participants receive either best medical therapy alone or thoracic endovascular aortic repair plus best medical therapy to manage acute uncomplicated type B aortic dissection.

Visits as per treatment schedule depending on assigned arm

Follow-up

Duration - Up to 5 years

Participants are monitored for outcomes including mortality, major morbidity events, and quality of life assessments.

Regular follow-up visits over 5 years

Trial Site Locations

Total: 2 locations

1

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

Houston, Texas, United States, 77030

Actively Recruiting

2

Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast

Houston, Texas, United States, 77089

Actively Recruiting

Loading map...

Research Team

H

Harleen K Sandhu, MD, MPH

K

Kristofer M Charlton-Ouw, MD, FACS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial.

Christoph A Nienaber, Hervé Rousseau, Holger Eggebrecht...

https://pubmed.ncbi.nlm.nih.gov/19996018

Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial.

Christoph A Nienaber, Stephan Kische, Hervé Rousseau...

https://pubmed.ncbi.nlm.nih.gov/23922146