Who is sponsoring NCT06029660?

NCT06029660 is sponsored by Shape Memory Medical, Inc..

What drugs are being tested in NCT06029660?

Interventions in NCT06029660: IMPEDE-FX RapidFill Implants, EndoVascular Aneurysm Repair.

What condition does NCT06029660 study?

NCT06029660 studies Aortic Aneurysm, Abdominal.

Is NCT06029660 still recruiting?

NCT06029660 is currently recruiting now. Last updated 2 May 2026.

Last reviewed 2026-05-02 · How we verify

NCT06029660

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now NA Last updated 2 May 2026

What this trial tests

NA trial testing IMPEDE-FX RapidFill Implants in Aortic Aneurysm, Abdominal in 180 participants. Currently enrolling.

Timeline

5 April 2024

Primary endpoint
1 June 2027

1 June 2031

Quick facts

Lead sponsor	Shape Memory Medical, Inc.
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	180
Start date	5 April 2024
Primary completion	1 June 2027
Estimated completion	1 June 2031
Sites	49 locations across United States, France, Netherlands, New Zealand, United Kingdom

Drugs / interventions tested

IMPEDE-FX RapidFill Implants
EndoVascular Aneurysm Repair

Conditions studied

Aortic Aneurysm, Abdominal — all drugs for Aortic Aneurysm, Abdominal →

Sponsor

Shape Memory Medical, Inc. — full company profile →

Who can join

18 and older, any sex, with Aortic Aneurysm, Abdominal. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
Time frame: 1 year
The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.
Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
Time frame: 30 days
Freedom from the following through 30 days post-index procedure: * Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss \>1000 mL. * AAA-rupture or AAA-perforation * Conversion to Open Repair

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Body-responsive shape-memory polymers for biomedical applications.
Tajik E, Reihani N, Karamzadeh V, Tang G, et al · · 2026 · PMID 41657946 · DOI 10.1016/j.bioactmat.2025.12.054
Endovascular Aneurysm Sealing: Sealed, Signed, Disposed?
Teraa M, van Herwaarden JA. · · 2025 · PMID 40687319 · DOI 10.1016/j.ejvsvf.2025.05.006

Verify or expand the search:

Other recruiting trials for Aortic Aneurysm, Abdominal

Currently open trials in the same condition.

NCT06488898 — Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts · Phase 2 · recruiting
NCT05972018 — Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters · Phase 4 · recruiting
NCT04503395 — ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES · NA · recruiting
NCT05360108 — Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm · active not recruiting
NCT02489539 — Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms · NA · active not recruiting

Other Shape Memory Medical, Inc. trials

Trials by the same sponsor.

NCT06740721 — False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_FRA) · NA · not yet recruiting
NCT07387250 — False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL) · NA · not yet recruiting
NCT06550986 — False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study · NA · recruiting
NCT04751578 — Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands · NA · active not recruiting
NCT04227054 — Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06029660 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shape Memory Medical, Inc.
Last refreshed: 2 May 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06029660.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing