Improving outcomes for patients with type B aortic dissection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of an upfront invasive strategy using TEVAR (Thoracic Endovascular Aortic Repair) combined with medical therapy against a conservative strategy of medical therapy and surveillance in patients with uncomplicated type B aortic dissection. Patients will be randomized within 48 hours to 6 weeks after their initial admission to one of the two treatment strategies. Follow-up will be conducted through a centralized call center and medical record review, with remote blood pressure monitoring to assess outcomes. The study will also provide recommendations for medical therapy while allowing the clinical care team to manage subsequent care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 21 years
2. Patients with a Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion syndrome (renal, mesenteric, or extremity) who are within 48 hours to 6 weeks after start of index admission for their type B dissection
3. Ability to provide written informed consent
4. Investigator believes anatomy is suitable for TEVAR

Exclusion Criteria:

1. Ongoing systemic infection
2. Pregnant or planning to become pregnant in the next 3 months
3. Life expectancy related to non-aortic conditions \< 2 years
4. Unwilling or unable to comply with all study procedures
5. Known patient history of genetic aortopathy
6. Penetrating Aortic Ulcer without concomitant uTBAD
7. Intramural hematoma without concomitant uTBAD
8. Iatrogenic (traumatic) aortic dissection

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Honorhealth
  Phoenix, Arizona, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Memorial Care Long Beach Medical Center
  Long Beach, California, United States Recruiting
• Keck Medical Center of USC
  Los Angeles, California, United States Recruiting
• Kaiser Permanente San Francisco
  Pleasanton, California, United States Recruiting

+16 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Manesh R Patel, M.D. — Duke University
• Study coordinator: Megan Roebuck, M.S.
• Email: megan.roebuck@duke.edu
• Phone: 919-316-0628

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Exercise program after endovascular repair for Type B aortic dissection

  This trial will test whether a supervised three-month exercise-based cardiac rehabilitation program is safe and helpful for people who had endovascular repair for Type B aortic dissection, intramural hematoma, or penetrating ulcer.

  Recruiting Guangdong Provincial People's Hospital · Guangzhou, Guangdong · NCT07009067

• Treatment for Type B Aortic Dissection using Allay Aortic Stent

  This study is testing if adding the Allay® Aortic Stent to standard treatment can help people with Type B aortic dissection avoid serious complications and aortic growth.

  Recruiting at 16 sites Intressa Vascular SA · Salzburg and 20 other locations · NCT06675617

• Evaluation of a new stent graft system for treating aortic arch and descending thoracic aorta conditions

  This study is testing a new stent graft system to see if it can safely help people with problems in their aortic arch and descending thoracic aorta, like aneurysms and dissections.

  Recruiting at 2 sites Ceric Sàrl · Brest and 3 other locations · NCT05479305

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.