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

NCT03207568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-07-05

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Thoracic Endovascular Aortic Repair (TEVAR)

thoracic endovascular repair (TEVAR) with a thoracic stent-graft

Sponsors & Collaborators

  • Bolton Medical

    lead INDUSTRY

Principal Investigators

  • Vicenç Riambau · Thorax Institute Hospital Clínic de Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-25
Primary Completion
2016-04-14
Completion
2016-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207568 on ClinicalTrials.gov