Last reviewed · How we verify
NCT06740721: FLAGSHIP_FRA
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_FRA)
NA trial testing False Lumen Embolization System, IMPEDE-FX RapidFill in Aortic Dissection in 15 participants. Not yet recruiting.
4 January 2027
Quick facts
| Lead sponsor | Shape Memory Medical, Inc. |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 October 2026 |
| Primary completion | 4 January 2027 |
| Estimated completion | 3 January 2029 |
Drugs / interventions tested
- False Lumen Embolization System, IMPEDE-FX RapidFill
Conditions studied
- Aortic Dissection — all drugs for Aortic Dissection →
Sponsor
Shape Memory Medical, Inc. — full company profile →
Who can join
18 and older, any sex, with Aortic Dissection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.
Publications & conference data
1 peer-reviewed publication 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
Verify or expand the search:
- PubMed search for NCT06740721
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of False Lumen Embolization System, IMPEDE-FX RapidFill
Trials testing the same drug.
- 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
Other recruiting trials for Aortic Dissection
Currently open trials in the same condition.
- NCT06550986 — False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study · NA · recruiting
- NCT06968806 — Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection · Phase 3 · recruiting
- NCT06827990 — GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections · NA · recruiting
- NCT06915545 — Study on the Aortic Arch Single Branch Stent Graft System · NA · recruiting
- NCT07117825 — Aortic Dissection fAlse enlarGement radIomics predictiOn · active not recruiting
Other Shape Memory Medical, Inc. trials
Trials by the same sponsor.
- 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
- 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)
- Trial protocol + status: ClinicalTrials.gov NCT06740721 (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: 29 January 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/NCT06740721.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing