NCT03207568

RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)

RE-GENERATION: An EU Clinical Study to Evaluate the Safety and Performance of the Relay Pro and Relay Non Bare Stent (NBS) Pro Stent-graft Devices in Patients With Thoracic Aortic Pathologies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bolton Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, multicenter, non-randomized, single arm clinical study in patients presenting thoracic aortic pathologies. Patients with thoracic aortic pathologies who are planned to undergo thoracic endovascular aortic repair (TEVAR) with a stent-graft based on routine clinical assessments performed as part of the patients' standard care will be screened after obtaining the informed consent from the patients, and if eligible, enrolled and scheduled for the implantation procedure with the study device. Following a baseline assessment, the implantation procedure will be performed according to the Instructions for Use and local routine practice. A follow-up visit will be performed 30 days after the implantation procedure. The investigator will perform assessments of the implantation procedure and device system and document adverse events and device deficiencies.

Conditions

• Aorta, Thoracic Pathologies
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Thoracic Endovascular Aortic Repair (TEVAR)	thoracic endovascular repair (TEVAR) with a thoracic stent-graft

Timeline

• Start date: 2014-10-25
• Primary completion: 2016-04-14
• Completion: 2016-04-30
• First posted: 2017-07-05
• Last updated: 2017-07-05