MedTrace Logo

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

NCT06029660 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Aneurysm, Abdominal

Interventions

DEVICE

IMPEDE-FX RapidFill Implants

Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants

PROCEDURE

EndoVascular Aneurysm Repair

Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Shape Memory Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Marc Schermerhorn, M.D. · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2027-06-30
Completion
2031-06-30
FDA Device
Yes

Countries

  • United States
  • France
  • Netherlands
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06029660 on ClinicalTrials.gov