Improving outcomes for patients with type B aortic dissection
IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 63 sites (Birmingham, Alabama and 62 other locations) |
| Trial ID | NCT06087029 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
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Honorhealth — Phoenix, Arizona, 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)
- University of California San Diego — San Diego, California, United States (Withdrawn)
- University of California — San Francisco, California, United States (Recruiting)
- Stanford University Medical Center — Stanford, California, United States (Withdrawn)
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
- Memorial Hospital Central — Colorado Springs, Colorado, United States (Recruiting)
- Hartford Hospital — Hartford, Connecticut, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Florida Health — Gainesville, Florida, United States (Recruiting)
- Tampa General Hospital — Tampa, Florida, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- The University of Chicago — Chicago, Illinois, United States (Withdrawn)
- Southern Illinois University School of Medicine — Springfield, Illinois, United States (Recruiting)
- Indiana University Methodist Hospital — Indianapolis, Indiana, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- MaineHealth — Scarborough, Maine, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Massachusetts Memorial — Worcester, Massachusetts, United States (Recruiting)
- University of Michigan Health — Ann Arbor, Michigan, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- Spectrum Health and Hospitals and Corewell — Grand Rapids, Michigan, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Withdrawn)
- University of Missouri Health Care — Columbia, Missouri, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Withdrawn)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Withdrawn)
- Cooper University Hospital — Camden, New Jersey, United States (Recruiting)
- Rutgers UH Vascular Center — Jersey City, New Jersey, United States (Recruiting)
- Maimonides Medical Center — Brooklyn, New York, United States (Withdrawn)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- St. Francis Hospital and Heart Center — Roslyn, New York, United States (Recruiting)
- Stony Brook University Medical Center — Stony Brook, New York, United States (Recruiting)
- SUNY Upstate Medical University — Syracuse, New York, United States (Recruiting)
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Withdrawn)
- Sanger Heart & Vascular Institute — Charlotte, North Carolina, United States (Withdrawn)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Harrington Heart and Vascular Institute — Cleveland, Ohio, United States (Recruiting)
- The Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- UT Dell Medical School- Ascension — Austin, Texas, United States (Recruiting)
+13 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.