JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Conditions

• AAA
• AAA - Abdominal Aortic Aneurysm

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Alto Abdominal Stent Graft System — DEVICE
  Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
• FDA Approved EVAR AAA Graft Systems — DEVICE
  FDA approved comparator of choice

Study Details

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).

Key Dates

Start date

Sep 20, 2021

Status verified

Jun 2025

Primary completion

Mar 31, 2031

Completion

Mar 31, 2031

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Alto Abdominal Stent Graft System
  Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.
• Active Comparator: Comparators
  Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.

Primary Outcome Measure

Number of Participants with Freedom from Aneurysm-Related Complications (ARC) [ Time Frame: Through 5 years ]

Central Contacts

• Noel DeSisto
  864-270-8524
  [email protected]
• Sanjana Tabassum
  [email protected]

Locations (29)

Find similar trials in Huntsville, AL

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