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NCT04244188
Simulation of Stent-graft Deployment in Aortic Arch Aneurysms
trial testing Collection of datas in Aortic Arch Aneurysm in 4 participants. Completed in 31 January 2019.
31 January 2019
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Saint Etienne |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 4 |
| Start date | 1 January 2019 |
| Primary completion | 31 January 2019 |
| Estimated completion | 31 January 2019 |
| Sites | 2 locations across France, Netherlands |
Drugs / interventions tested
- Collection of datas
Conditions studied
- Aortic Arch Aneurysm — all drugs for Aortic Arch Aneurysm →
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Who can join
18 and older, any sex, with Aortic Arch Aneurysm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, the investigators aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04244188
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Currently open trials in the same condition.
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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 NCT04244188 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Saint Etienne
- Last refreshed: 18 November 2023
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/NCT04244188.
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