NCT05639400

Thoraflex Hybrid and Relay Extension Post-Approval Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 352 (actual)
• Sponsor: Vascutek Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Type	Name	Description
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.

Timeline

• Start date: 2023-03-17
• Primary completion: 2035-07-01
• Completion: 2036-03-01
• First posted: 2022-12-06
• Last updated: 2026-02-06

Locations

27 sites across 7 countries: United States, Austria, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated device study