Terumo Aortic Global Endovascular Registry
Part of paid clinical trials in Long Beach, California.
- Sponsor
- Vascutek Ltd.
- Study ID
- NCT04246463
- Status
- Recruiting
Conditions
- Abdominal Aortic Aneurysm
- Surgery
- Thoracic Aortic Aneurysm
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Thoracic — DEVICEImplant of a Relay stent graft system
- Abdominal — DEVICEImplant with an Anaconda or Treo Stent graft system
- Custom Device — DEVICEImplant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
- Illiac Artery — DEVICEImplant with an Anaconda Iliac leg only
Study Details
Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.
Key Dates
- Start date
- Dec 17, 2019
- Status verified
- Jul 2025
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2030
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: Thoracic - TEVAR
- Arm: Abdominal - EVAR
- Arm: Custom Device
- Arm: Other indicationsIsolated Iliac Artery Aneurysm (IIAA)
Primary Outcome Measure
Aortic Related Mortality [ Time Frame: 30 days post implant ]
Central Contacts
- Michelle Durnan+44 141 343 0195
- Sammy Jassal+44 141 343 0195
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | Ali Khoynezhad (PRINCIPAL_INVESTIGATOR) |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | Rafael Malgor, MD (PRINCIPAL_INVESTIGATOR) |
| UC Health Memorial Hospital Center | Colorado Springs | Colorado | 80909 | Melham Sharafuddin (PRINCIPAL_INVESTIGATOR) |
| Yale University | New Haven | Connecticut | 06520 | Prashanth Vallabhajoysyula (PRINCIPAL_INVESTIGATOR) |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Christian Shults (PRINCIPAL_INVESTIGATOR) |
| University of Florida | Gainesville | Florida | 32610 | Eric Jeng (PRINCIPAL_INVESTIGATOR) |
| Loyola University of Chicago (Loyola) | Chicago | Illinois | 60153 | Carlos Bechara, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension St. Vincent Heart Center | Indianapolis | Indiana | 46260 | Sina L Moainie, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | Shinichi Fukuhara, MD (PRINCIPAL_INVESTIGATOR) |
| Cooper University Hospital | Camden | New Jersey | 08103 | Joseph Lombardi (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Wilson Szeto (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | Ibrahim Sulton (PRINCIPAL_INVESTIGATOR) |
| Ascension Texas Cardiovascular / UT Dell Medical School | Austin | Texas | 78705 | Joshua Grimm (PRINCIPAL_INVESTIGATOR) |
| Baylor, Scott & White Health (BSW Health) | Texas City | Texas | 75093 | Dennis Gable, MD (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84132 | Jason Glozbach (PRINCIPAL_INVESTIGATOR) |
| University of Virgina | Charlottesville | Virginia | 22908 | Bezhad Farivar (PRINCIPAL_INVESTIGATOR) |
| Sentara Heart Hospital | Norfolk | Virginia | 22042 | Jean Panneton, MD (PRINCIPAL_INVESTIGATOR) |
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