Last reviewed · How we verify
NCT05126446
the Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration
NA trial testing the Aorta Arch Stent Graft System combined with the Endovascular Needle System in Aortic Dissection in 120 participants. Participants enrolled and being followed up; not accepting new ones.
30 October 2027
Quick facts
| Lead sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 25 July 2021 |
| Primary completion | 30 October 2027 |
| Estimated completion | 30 March 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- the Aorta Arch Stent Graft System combined with the Endovascular Needle System
Conditions studied
- Aortic Dissection — all drugs for Aortic Dissection →
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd. — full company profile →
Who can join
Adults 18 to 80, any sex, with Aortic Dissection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prospective, multi-center, single-group target value method to evaluate the safety and effectiveness of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in situ fenestration technology in the treatment of aortic dissection involving the aortic arch
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
First-in-Human Implantation of Gutter-Free Design Stent-Graft in <i>in situ</i> Fenestration TEVAR for Aortic Arch Pathology.
Li X, Shu C, Wang L, Li Q, et al · · 2022 · cited 1× · PMID 35845060 · DOI 10.3389/fcvm.2022.911689 -
Early Results of a Single-Center Prospective Clinical Trial: In Situ Fenestration System for Aortic Dissection.
Tan Y, Chen W, Li Z, Xu H, et al · · 2025 · PMID 40289333 · DOI 10.1177/15385744251330013
Verify or expand the search:
- PubMed search for NCT05126446
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Lifetech Scientific (Shenzhen) Co., Ltd. trials
Trials by the same sponsor.
- NCT07385599 — FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients · NA · active not recruiting
- NCT06915545 — Study on the Aortic Arch Single Branch Stent Graft System · NA · recruiting
- NCT06849635 — Cera™ ASD Occluder Post-Market Clinical Follow-Up Study · recruiting
- NCT06700174 — Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study · recruiting
- NCT06520774 — Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases · NA · recruiting
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 NCT05126446 (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 Lifetech Scientific (Shenzhen) Co., Ltd.
- Last refreshed: 23 July 2024
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/NCT05126446.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing