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NCT06029660 · ClinicalTrials.gov registry record · NA

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

A NA study of Aortic Aneurysm, Abdominal, sponsored by Shape Memory Medical.

Recruiting
Registry status
NA
Development phase
180
Enrollment target
20
Study locations

NCT06029660 is a NA study of Aortic Aneurysm, Abdominal that is actively recruiting participants, run by Shape Memory Medical. The registered enrollment target is 180 participants, above the 132-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (36% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT06029660, a NA study of Aortic Aneurysm, Abdominal, is actively recruiting participants, sponsored by Shape Memory Medical.

RECRUITING
Registry status
NA
Development phase
180 participants
Enrollment target
20
Study locations

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 Studied

Aortic Aneurysm, Abdominal

Interventions

  • DEVICE IMPEDE-FX RapidFill Implants
  • PROCEDURE EndoVascular Aneurysm Repair

Study Locations (20)

Florida

  • Delray Medical Center - Delray Beach
  • Orlando Health - Orlando
  • University of South Florida - Tampa

Massachusetts

  • Massachusetts General Hospital - Boston
  • Brigham & Women's Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston

California

  • USC Keck - Los Angeles
  • San Diego VA Medical Center - San Diego

Michigan

  • VA Ann Arbor Healthcare - Ann Arbor
  • Corewell Health - Grand Rapids

Alabama

  • University of Alabama Birmingham - Birmingham

Arizona

  • Honor Health - Scottsdale

Georgia

  • Emory University Hospital - Atlanta

Illinois

  • University of Chicago - Chicago

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2024-04-05
Est. Completion 2031-06
Phase NA

Sponsor

Shape Memory Medical

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06029660

The ClinicalTrials.gov registry entry for NCT06029660 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 132-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (36% higher). The listed sponsor is Shape Memory Medical, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Aortic Aneurysm, Abdominal appearing as the primary indexed condition, and to 2 interventions - of which IMPEDE-FX RapidFill Implants is the first listed.

NCT06029660 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, Massachusetts, California.

Frequently Asked Questions

What is clinical trial NCT06029660 about?

NCT06029660 is a clinical study titled "AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion". 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 electi...

What is the current status of trial NCT06029660?

This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2024-04-05. Estimated completion is 2031-06.

What conditions does trial NCT06029660 study?

This clinical trial studies the following conditions: Aortic Aneurysm, Abdominal.

What interventions are being tested in trial NCT06029660?

The interventions under investigation include: IMPEDE-FX RapidFill Implants (DEVICE), EndoVascular Aneurysm Repair (PROCEDURE).

Who is sponsoring clinical trial NCT06029660?

This trial is sponsored by Shape Memory Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06029660 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.