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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)

Completed NA Last updated 5 July 2017
What this trial tests

NA trial testing Thoracic Endovascular Aortic Repair (TEVAR) in Aorta, Thoracic Pathologies in 30 participants. Completed in 30 April 2016.

Timeline
25 October 2014
Primary endpoint
14 April 2016
30 April 2016

Quick facts

Lead sponsorBolton Medical
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date25 October 2014
Primary completion14 April 2016
Estimated completion30 April 2016

Drugs / interventions tested

Conditions studied

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):

  1. 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

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Other Bolton Medical trials

Trials by the same sponsor.

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Data sources for this page

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