GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- W.L.Gore & Associates
- Study ID
- NCT06827990
- Status
- Recruiting
Conditions
- Aortic Dissection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- GORE® Ascending Stent Graft (ASG device) — DEVICEEndovascular aortic repair of the ascending aorta
Study Details
To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
Key Dates
- Start date
- Sep 22, 2025
- Status verified
- Apr 2026
- Primary completion
- Sep 1, 2030
- Completion
- Sep 1, 2031
Study Design
- Enrollment
- 112 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: PrimaryA hypothesis driven analysis of the safety and effectiveness of the GORE® Ascending Stent Graft (ASG) device alone in the ascending aorta. Dissection chronicity in the primary arm must be 30 days or less from symptom onset to index endovascular procedure.
- Experimental: SecondaryDescriptive analysis of use of the ASG device in patients who are not eligible for treatment in the primary arm. Dissection chronicity up to 90 days from symptom onset until the first study procedure is allowed in the secondary arm.
Primary Outcome Measure
Primary Safety Endpoint [ Time Frame: 30 Days ]
Central Contacts
- Clinical Study Manager800-437-8181
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Kyle Eudailey, MD (PRINCIPAL_INVESTIGATOR) |
| University of Southern California | Los Angeles | California | 90033 | Arnoldo Gutierres-Abrica Fernando Fleischman, MD (PRINCIPAL_INVESTIGATOR) |
| University of Florida | Gainesville | Florida | 32608 | Thomas Beaver, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | Maialen Odriozola Bradley Leshnower, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern Medicine | Chicago | Illinois | 60611 | Christopher Mehta, MD (PRINCIPAL_INVESTIGATOR) |
| Indiana University | Indianapolis | Indiana | 46202 | Emily Rettig Joel Corvera, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Bronwen Rees-Widermann Arminder Jassar, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | Himanshu Patel, MD (PRINCIPAL_INVESTIGATOR) |
| Corewell Health System | Grand Rapids | Michigan | 49503 | Denise Wittenbach Stephane Leung, MD (PRINCIPAL_INVESTIGATOR) |
| Washington University School of Medicine - St. Louis | St Louis | Missouri | 63110 | Allison Schuck Puja Kachroo, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University Medical Center | Durham | North Carolina | 27710 | G. Chad Hughes, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Patrick Vargo, MD (PRINCIPAL_INVESTIGATOR) |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | Theresa Khuat Jefferson Lyons, MD (PRINCIPAL_INVESTIGATOR) |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 18104 | Tara Manzari Nimesh Desai, MD (PRINCIPAL_INVESTIGATOR) |
| The Methodist Hospital Houston | Houston | Texas | 77030 | Marvin Atkins, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor Research Institute | Plano | Texas | 75093 | William Brinkman, MD (PRINCIPAL_INVESTIGATOR) |
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