NCT04751578 (AAA-SHAPE_NLD) is a NA clinical trial of IMPEDE-FX Embolization Plug in Abdominal Aortic Aneurysm, sponsored by Shape Memory Medical, Inc..

Who is sponsoring NCT04751578?

NCT04751578 is sponsored by Shape Memory Medical, Inc..

What drugs are being tested in NCT04751578?

Interventions in NCT04751578: IMPEDE-FX Embolization Plug.

What condition does NCT04751578 study?

NCT04751578 studies Abdominal Aortic Aneurysm.

Is NCT04751578 still recruiting?

NCT04751578 is currently active, enrolled. Last updated 22 December 2025.

Last reviewed 2025-12-22 · How we verify

NCT04751578: AAA-SHAPE_NLD

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

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands

Active, enrolled NA Last updated 22 December 2025

What this trial tests

NA trial testing IMPEDE-FX Embolization Plug in Abdominal Aortic Aneurysm in 15 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 July 2021

Primary endpoint
13 April 2022

30 April 2027

Quick facts

Lead sponsor	Shape Memory Medical, Inc.
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	13 July 2021
Primary completion	13 April 2022
Estimated completion	30 April 2027
Sites	3 locations across Netherlands

Drugs / interventions tested

IMPEDE-FX Embolization Plug

Conditions studied

Abdominal Aortic Aneurysm — all drugs for Abdominal Aortic Aneurysm →

Sponsor

Shape Memory Medical, Inc. — full company profile →

Who can join

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

Sponsor's own description

To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.

Publications & conference data

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

Active aortic aneurysm sac treatment with shape memory polymer during endovascular aneurysm repair.
Holden A, Hill AA, Khashram M, Heyligers JMM, et al · · 2023 · cited 3× · PMID 37496654 · DOI 10.1016/j.jvscit.2023.101241
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

Verify or expand the search:

Other trials of IMPEDE-FX Embolization Plug

Trials testing the same drug.

NCT04227054 — Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks · NA · active not recruiting

Other recruiting trials for Abdominal Aortic Aneurysm

Currently open trials in the same condition.

NCT07476196 — Poland-Italy Aortic Research Bridge Real World Registry · recruiting
NCT07473102 — PET Imaging of MMP Activation in AAA: Clinical Component · EARLY_PHASE1 · recruiting
NCT06451315 — REGISTRY on the Implementation of Artificial Intelligence in the Automatic Analysis of Vascular Network Segmentation · recruiting
NCT06001918 — Nectero EAST System Clinical Study · Phase 2, PHASE3 · recruiting
NCT06008613 — 3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair · 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
NCT04227054 — Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks · NA · active not recruiting
NCT03988062 — Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study · NA · completed

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 NCT04751578 (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: 22 December 2025

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/NCT04751578.

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