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 — DEVICE
    Implant of a Relay stent graft system
  • Abdominal — DEVICE
    Implant with an Anaconda or Treo Stent graft system
  • Custom Device — DEVICE
    Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
  • Illiac Artery — DEVICE
    Implant 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 indications
    Isolated Iliac Artery Aneurysm (IIAA)

Primary Outcome Measure

Aortic Related Mortality [ Time Frame: 30 days post implant ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Long Beach Memorial Medical CenterLong BeachCalifornia90806
Ali Khoynezhad (PRINCIPAL_INVESTIGATOR)
University of Colorado Anschutz Medical CampusAuroraColorado80045
Rafael Malgor, MD (PRINCIPAL_INVESTIGATOR)
UC Health Memorial Hospital CenterColorado SpringsColorado80909
Melham Sharafuddin (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06520
Prashanth Vallabhajoysyula (PRINCIPAL_INVESTIGATOR)
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Christian Shults (PRINCIPAL_INVESTIGATOR)
University of FloridaGainesvilleFlorida32610
Eric Jeng (PRINCIPAL_INVESTIGATOR)
Loyola University of Chicago (Loyola)ChicagoIllinois60153
Carlos Bechara, MD (PRINCIPAL_INVESTIGATOR)
Ascension St. Vincent Heart CenterIndianapolisIndiana46260
Sina L Moainie, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Shinichi Fukuhara, MD (PRINCIPAL_INVESTIGATOR)
Cooper University HospitalCamdenNew Jersey08103
Joseph Lombardi (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Wilson Szeto (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15232
Ibrahim Sulton (PRINCIPAL_INVESTIGATOR)
Ascension Texas Cardiovascular / UT Dell Medical SchoolAustinTexas78705
Joshua Grimm (PRINCIPAL_INVESTIGATOR)
Baylor, Scott & White Health (BSW Health)Texas CityTexas75093
Dennis Gable, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Jason Glozbach (PRINCIPAL_INVESTIGATOR)
University of VirginaCharlottesvilleVirginia22908
Bezhad Farivar (PRINCIPAL_INVESTIGATOR)
Sentara Heart HospitalNorfolkVirginia22042
Jean Panneton, MD (PRINCIPAL_INVESTIGATOR)

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