AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Conditions

• Aortic Aneurysm, Abdominal

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IMPEDE-FX RapidFill Implants — DEVICE
  Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
• EndoVascular Aneurysm Repair — PROCEDURE
  Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.

Study Details

To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.

Key Dates

Start date

Apr 5, 2024

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2031

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
• Active Comparator: Control
  Control Arm: Subjects in the control arm will only have an EVAR device implanted.

Primary Outcome Measure

Primary Effectiveness Endpoint : AAA Sac Regression at 1 year [ Time Frame: 1 year ]

Central Contacts

• Ann Martin
  707.849.2213
  [email protected]
• Peter Miller, M.S.
  [email protected]

Locations (39)

Find similar trials in Birmingham, AL

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