ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

Part of paid clinical trials in La Jolla, California.

Sponsor
FCRE (Foundation for Cardiovascular Research and Education)
Study ID
NCT04503395
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Aneurysm, Abdominal

Eligibility Criteria

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

Interventions

  • ESAR treatment: Endograft + Heli-FX Endoanchor — DEVICE
    ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
  • FEVAR treatment : Fenestrated endograft — DEVICE
    Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft

Study Details

The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).

Key Dates

Start date
May 21, 2021
Status verified
May 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2032

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ESAR
    Endovascular Aneurysm Repair + Heli-FX EndoAnchors
  • Active Comparator: FEVAR
    Fenestrated EndoVascular Aneurysm Repair

Primary Outcome Measure

Effectiveness Endpoint - Technical Success [ Time Frame: through 12 months post-procedure ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
UCSD Medical Center HillcrestLa JollaCalifornia92037-
Stanford UniversityStanfordCalifornia94305
Jason Lee
University of FloridaGainesvilleFlorida32608-
Corewell Health (Spectrum)Grand RapidsMichigan49503-
Mount Sinai HospitalNew YorkNew York10029
Rami Tadros
Oklahoma HeartTulsaOklahoma74104
Adel Barkat
Providence Portland Medical CenterPortlandOregon97213-
Allegheny General HospitalPittsburghPennsylvania14212-
Sentara Norfolk General HospitalNorfolkVirginia23507
Hosam El-Sayed

Find similar trials in La Jolla, CA

By research site
UCSD Medical Center Hillcrest· La Jolla, CAStanford University· Stanford, CAUniversity of Florida· Gainesville, FLCorewell Health (Spectrum)· Grand Rapids, MIMount Sinai Hospital· New York, NYOklahoma Heart· Tulsa, OK

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