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NCT03207568: RE-GENERATION
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
NA trial testing Thoracic Endovascular Aortic Repair (TEVAR) in Aorta, Thoracic Pathologies in 30 participants. Completed in 30 April 2016.
14 April 2016
Quick facts
| Lead sponsor | Bolton Medical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 25 October 2014 |
| Primary completion | 14 April 2016 |
| Estimated completion | 30 April 2016 |
Drugs / interventions tested
- Thoracic Endovascular Aortic Repair (TEVAR)
Conditions studied
- Aorta, Thoracic Pathologies — all drugs for Aorta, Thoracic Pathologies →
- Aortic Aneurysm, Thoracic — all drugs for Aortic Aneurysm, Thoracic →
- Aortic Aneurysm — all drugs for Aortic Aneurysm →
Sponsor
Bolton Medical — full company profile →
Who can join
Adults 18 to 85, any sex, with Aorta, Thoracic Pathologies or Aortic Aneurysm, Thoracic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic pathologies. Clinical results will be used to apply for the CE certification.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Hybrid repair versus conventional open repair for thoracic aortic arch aneurysms.
Elhelali A, Hynes N, Devane D, Sultan S, et al · · 2021 · cited 13× · PMID 34085713 · DOI 10.1002/14651858.cd012923.pub2
Verify or expand the search:
- PubMed search for NCT03207568
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Bolton Medical trials
Trials by the same sponsor.
- NCT07026877 — Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA · NA · recruiting
- NCT04697784 — Post-Approval Study of the TREO Abdominal Stent-Graft System · NA · active not recruiting
- NCT03214601 — Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System · NA · active not recruiting
- NCT03187522 — An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft · NA · terminated
- NCT03090230 — Study of the Relay Pro® Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta · 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)
- Trial protocol + status: ClinicalTrials.gov NCT03207568 (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 Bolton Medical
- Last refreshed: 5 July 2017
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/NCT03207568.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing