MedTrace Logo

Thoraflex Hybrid and Relay Extension Post-Approval Study

NCT05639400 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 352

Last updated 2026-02-06

No results posted yet for this study

Summary

The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta.

Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site.

Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.

Conditions

  • Thoracic Diseases
  • Aortic Aneurysm
  • Aortic Dissection
  • Thoracic Aortic Aneurysm
  • Thoracic Aortic Dissection

Interventions

DEVICE

Thoraflex Hybrid

Thoraflex Hybrid is designed for the open surgical repair of aneurysms and/or dissections in the aortic arch and descending aorta with or without involvement of the ascending aorta. There are two types of Thoraflex Hybrid implants, namely the Plexus 4 and the Ante-Flo versions. Each patient receives one Thoraflex Hybrid device (either the Plexus 4 or Ante-Flo).

DEVICE

RelayPro NBS

The RelayPro NBS Thoracic Stent-Graft System is an endovascular device intended for treatment of thoracic aortic pathologies such as aneurysms, pseudoaneurysms, dissections, penetrating ulcers and intramural hematoma.

Sponsors & Collaborators

  • Bolton Medical

    collaborator INDUSTRY

  • Vascutek Ltd.

    lead INDUSTRY

Principal Investigators

  • Martin Czerny · University of Freiburg

  • Joseph E Bavaria · Jefferson Health and Sidney Kimmel Medical College

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-17
Primary Completion
2035-07-31
Completion
2036-03-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT05639400 on ClinicalTrials.gov