Improving outcomes for patients with type B aortic dissection

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Not applicable Interventional Duke University · NCT06087029

This study is testing whether a more aggressive treatment using a special procedure combined with medication can help people with type B aortic dissection do better than just using medication and regular check-ups.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1100 (estimated)
Ages21 Years and up
SexAll
SponsorDuke University Academic / other
Locations63 sites (Birmingham, Alabama and 62 other locations)
Trial IDNCT06087029 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 21 years with uncomplicated type B aortic dissection who can provide informed consent.

Not a fit: Patients with ongoing systemic infections, life expectancy under two years due to non-aortic conditions, or those with a history of genetic aortopathy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of death and major aortic complications in patients with type B aortic dissection.

How similar studies have performed: Other studies have shown promising results with similar invasive strategies for aortic dissection, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria
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 this trial is running

Birmingham, Alabama and 62 other locations

+13 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Type B Aortic DissectionTEVAR
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.