IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: Duke University
Study ID: NCT06087029
Status: Recruiting

Apply to this trial

Conditions

Type B Aortic Dissection

Eligibility Criteria

Sex: ALL
Age: 21 Years - N/A
Healthy Volunteers: Not accepted

Interventions

TEVAR — PROCEDURE
Thoracic endovascular aortic repair
Guideline directed medical therapy and surveillance of dissection — OTHER
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

Study Details

The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.

Key Dates

Start date: Apr 14, 2024
Status verified: Feb 2026
Primary completion: Jun 1, 2030
Completion: Jun 30, 2030

Study Design

Enrollment: 1,100 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Upfront TEVAR plus Medical Therapy
Participants randomized to upfront TEVAR will receive a commercially available device customized to their individual anatomical requirements. Stent-graft implantation will be performed either in the operating room with appropriate digital imaging equipment to allow fluoroscopic and trans-esophageal echo (TEE) guidance or the catheterization laboratory, angiographic suite (with digital angiographic equipment).
Active Comparator: Medical Therapy with surveillance for deterioration
Participants randomized to upfront Medical Therapy with Surveillance for Deterioration will be treated per routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

Primary Outcome Measure

All-cause death or major aortic complications (MAC) [ Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years ]

Central Contacts

Megan Roebuck, M.S.
919-316-0628
[email protected]
Kady-Ann Steen-Burrell, Ph.D.
919-530-9711
[email protected]

Locations (61)

Facility	City	State	ZIP	Site coordinators
University of Alabama at Birmingham	Birmingham	Alabama	35294	Adam Beck, MD Adam Beck, MD (PRINCIPAL_INVESTIGATOR)
Honorhealth	Phoenix	Arizona	85020	General Office Number 480-323-1046 Hasan Aldailami, MD (PRINCIPAL_INVESTIGATOR)
Memorial Care Long Beach Medical Center	Long Beach	California	90806	Rodney White, MD Rodney White, MD (PRINCIPAL_INVESTIGATOR)
Keck Medical Center of USC	Los Angeles	California	90033	Alyssa Pyun, MD Alyssa Pyun, MD (PRINCIPAL_INVESTIGATOR)
University of California San Diego	San Diego	California	92110	-
University of California	San Francisco	California	94143	Alexis Callanta 415-353-4368 Jade Hiramoto, MD (PRINCIPAL_INVESTIGATOR)
Stanford University Medical Center	Stanford	California	94305	-
University of Colorado Denver	Aurora	Colorado	80045	Brett Reece, MD Brett Reece (PRINCIPAL_INVESTIGATOR)
Memorial Hospital Central	Colorado Springs	Colorado	90803	Mel Sharafuddin, MD Mel Sharafuddin, MD (PRINCIPAL_INVESTIGATOR)
Hartford Hospital	Hartford	Connecticut	06102	Marianne McCarthy 860-972-1788 Mohiuddin Cheema, MD (PRINCIPAL_INVESTIGATOR)
Yale University	New Haven	Connecticut	06510	David Kuwayama, MD David Kuwayama, MD (PRINCIPAL_INVESTIGATOR)
University of Florida Health	Gainesville	Florida	32608	Nancy Hanson 352-273-7598 Michol Cooper, MD (PRINCIPAL_INVESTIGATOR)
Tampa General Hospital	Tampa	Florida	33606	Eric Johnson 813-844-4686 Halim Yammine, MD (PRINCIPAL_INVESTIGATOR)
Northwestern University	Chicago	Illinois	60611	Andrea Silverman 312-926-4000 Mark Eskandari, MD (PRINCIPAL_INVESTIGATOR)
The University of Chicago	Chicago	Illinois	60637	-
Southern Illinois University School of Medicine	Springfield	Illinois	62702	Rebecca Owens 217-545-7321 Laura Healy, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Methodist Hospital	Indianapolis	Indiana	46202	Raghu Motaganahalli, MD Raghu Motaganahalli, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical Center	Kansas City	Kansas	66160	William Poulson, MD William Poulson, MD (PRINCIPAL_INVESTIGATOR)
MaineHealth	Scarborough	Maine	04101	Monica Palmeri 207-662-2090 Kristina Giles, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University	Baltimore	Maryland	21230	Caitlin Hicks, MD Caitlin Hicks, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's Hospital	Boston	Massachusetts	02115	BWH Vascular Surgery Research 617-525-8555 Matthew T Menard, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital	Boston	Massachusetts	02114	Research Office 617-726-8875 Matthew Eagleton, MD (PRINCIPAL_INVESTIGATOR)
University of Massachusetts Memorial	Worcester	Massachusetts	01655	Shauneen Valliere 508-856-1767 Andres Schanzer, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Health	Ann Arbor	Michigan	48109	Bo Yang, MD Bo Yang, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health System	Detroit	Michigan	48202	Research Office 313-916-8006 Loay Kabbani, MD (PRINCIPAL_INVESTIGATOR)
Spectrum Health and Hospitals and Corewell	Grand Rapids	Michigan	49503	Eanas Yassa, MD Eanas Yassa, MD (PRINCIPAL_INVESTIGATOR)
University of Minnesota	Minneapolis	Minnesota	55455	Surgery Clinical Trials Office 612-624-7463 Nolan Cirillo-Penn, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic	Rochester	Minnesota	55905	-
University of Missouri Health Care	Columbia	Missouri	65212	Brianna Ledbetter 573-884-7569 Jonathan Bath, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine	St Louis	Missouri	63110	-
University of Nebraska Medical Center	Omaha	Nebraska	68198	-
Cooper University Hospital	Camden	New Jersey	08103	Jonelle O'Shea 856-342-2150 Philip Batista, MD (PRINCIPAL_INVESTIGATOR)
Rutgers UH Vascular Center	Jersey City	New Jersey	07302	Karim Salem, MD Karim Salem, MD (PRINCIPAL_INVESTIGATOR)
Maimonides Medical Center	Brooklyn	New York	11219	-
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Bridget Coyle 212-241-4461 Rami Tadros, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Health	New York	New York	10016	Gregory Magee, MD Gregory Magee, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical Center	Rochester	New York	14642	Mary Bourret 585-276-1738 Doran Mix, MD (PRINCIPAL_INVESTIGATOR)
St. Francis Hospital and Heart Center	Roslyn	New York	11576	Timothy Carter, MD Timothy Carter, MD (PRINCIPAL_INVESTIGATOR)
Stony Brook University Medical Center	Stony Brook	New York	11794	Apostolos Tassiopoulos, MD Apostolos Tassiopoulos, MD (PRINCIPAL_INVESTIGATOR)
SUNY Upstate Medical University	Syracuse	New York	13120	Maria Walker 315-464-8272 Palma Shaw, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina Chapel Hill	Chapel Hill	North Carolina	27599	-
Sanger Heart & Vascular Institute	Charlotte	North Carolina	28201	-
Duke University Medical Center	Durham	North Carolina	27710	G. Chad Hughes, MD G. Chad Hughes, MD (PRINCIPAL_INVESTIGATOR)
Harrington Heart and Vascular Institute	Cleveland	Ohio	44106	Amy Kluge 216-844-2988 Jae S Cho, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Medical Center	Columbus	Ohio	43210	Xiaoyi Teng, MD Xiaoyi Teng, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science University	Portland	Oregon	97239	Amie Lorisch 971-349-6659 Sherene Shalhub, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	19107	Babak Abai, MD Babak Abai, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Nimesh Desai, MD Nimesh Desai, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15213	Erin Cochran 412-647-8467 Derek Serna-Gallegos, MD (PRINCIPAL_INVESTIGATOR)
UT Dell Medical School- Ascension	Austin	Texas	78712	Madeline Gleason 512-324-3434 George Arnaoutakis, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White Research Institute	Dallas	Texas	75226	John Eidt, MD John Eidt, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical Center	Dallas	Texas	75390	Emma Bryant 214-648-6743 Michael Shih, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist Hospital	Houston	Texas	77030	Solange Basagoitia 832-301-1168 Saba Khan 832-301-1168 Marvin Atkins, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Houston	Houston	Texas	77030	Mariano Montemayor 713-486-5194 Naveed Saqib, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White The Heart Hospital - Plano	Plano	Texas	75093	Dennis Gable, MD Dennis Gable, MD (PRINCIPAL_INVESTIGATOR)
University of Utah	Salt Lake City	Utah	84112	Julie Hales 801-587-1450 Nathan Droz, MD (PRINCIPAL_INVESTIGATOR)
Sentara Cardiovascular Research Institute	Norfolk	Virginia	23507	Kara Wiggins 757-388-7511 David Dexter, MD (PRINCIPAL_INVESTIGATOR)
University of Washington	Seattle	Washington	98104	Benjamin Starnes, MD Benjamin Starnes, MD (PRINCIPAL_INVESTIGATOR)
CAMC Clinical Trials Center	Charleston	West Virginia	25304	Kristi Sutphin 304-388-9944 Shadi Abu-halimah, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin	Madison	Wisconsin	53792	John Rectenwald, MD John Rectenwald, MD (PRINCIPAL_INVESTIGATOR)
Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Beth Weseman 414-955-1810 Joe Hart, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site

University of Alabama at Birmingham· Birmingham, AL Honorhealth· Phoenix, AZ Memorial Care Long Beach Medical Center· Long Beach, CA Keck Medical Center of USC· Los Angeles, CA University of California San Diego· San Diego, CA University of California· San Francisco, CA

Related Studies

Transcutaneous Auricular Vagus Nerve Stimulation for Attenuation of Inflammatory Response and Blood Pressure in Type B Aortic Dissection
Not Yet Recruiting · Washington University School of Medicine · St Louis, Missouri