Thoraflex Hybrid and Relay Extension Post-Approval Study

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

March 17, 2023

Primary Completion Date

December 31, 2035

Study Completion Date

December 31, 2036

Conditions
Thoracic DiseasesAortic AneurysmAortic DissectionThoracic Aortic AneurysmThoracic 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.

Trial Locations (27)

5020

RECRUITING

Paracelsus Medical University, Salzburg

10065

RECRUITING

Weill Cornell medicine, New York

15213

RECRUITING

UPMC Presbyterian, Pittsburgh

19104

RECRUITING

University of Pennsylvania, Philadelphia

20010

RECRUITING

Medstar Washington Hospital Centre, Washington D.C.

21201

RECRUITING

University of Maryland, Baltimore

27710

RECRUITING

Duke University Medical Centre, Durham

31059

RECRUITING

CHU de Toulouse - Hôpital de Rangueil, Toulouse

35294

RECRUITING

University of Alabama in Birmingham Medical Center, Birmingham

46290

RECRUITING

Ascension St. Vincent Heart Center, Indianapolis

60611

RECRUITING

Northwestern University, Chicago

63110

RECRUITING

Washington University/Barnes Jewish Hospital, St Louis

77030

RECRUITING

Baylor College of Medicine - St. Luke's, Houston

78705

RECRUITING

UT Dell Medical / Ascension Texas Cardiovascular, Austin

80045

RECRUITING

University of Colorado, Aurora

84132

RECRUITING

University of Utah, Salt Lake City

90048

RECRUITING

Cedars-Sinai Medical Centre, Los Angeles

90089

RECRUITING

Keck Medical Centre of USC, Los Angeles

06106

RECRUITING

Hartford Hospital, Hartford

02114

RECRUITING

Massachusetts General Hospital, Boston

Unknown

RECRUITING

CHU Nantes, Saint-Herblain

RECRUITING

University of Freiburg, Freiburg im Breisgau

9 40138

RECRUITING

Policlinico Di S.Orsola, Universita' Di Bologna, Bologna

08036

NOT_YET_RECRUITING

Hospital Clinic of Barcelona, Barcelona

BS2 8HW

RECRUITING

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol

OX3 9DU

RECRUITING

Oxford University Hospitals NHS FT, Oxford

SO16 6YD

RECRUITING

Southampton General Hospital, Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bolton Medical

INDUSTRY

lead

Vascutek Ltd.

INDUSTRY

NCT05639400 - Thoraflex Hybrid and Relay Extension Post-Approval Study | Biotech Hunter | Biotech Hunter