Total Arch Replacement With Frozen Elephant Trunk Versus Hemiarch Replacement in the Management of Acute Type A Aortic Dissection

NANot yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

October 31, 2026

Primary Completion Date

June 30, 2029

Study Completion Date

October 31, 2029

Conditions
Aortic Dissection Type A
Interventions
PROCEDURE

Conventional hemiarch replacement

Conventional open hemiarch replacement

PROCEDURE

E-vita® Open Neo; Artivion

E-vita® Open Neo is a hybrid stent graft system for aortic arch and descending thoracic aorta repair with Frozen Elephant Trunk Technique.

PROCEDURE

Thoraflex Hybrid; Terumo

The Thoraflex Hybrid is a device system designed to repair a weakened and bulging section (aneurysm) and/or a tear in the lining (dissection) of the aorta behind the heart (aortic arch). The system includes a polyester graft section that reinforces a weakened section of the blood vessel, a connected stented section (nitinol wire frame on polyester graft material) that holds the artery open, and a delivery catheter that is used to place the device. The polyester graft and stented sections are coated with a protein substance taken from animal body parts (gelatin) to seal the implant and prevent blood from leaking out.

Trial Locations (3)

Unknown

University Hospital Vienna, Vienna

Prince of Wales Hospital, Hong Kong

Siriraj Hospital - Mahidol University, Bangkok

All Listed Sponsors
collaborator

University of Vienna

OTHER

collaborator

Mahidol University

OTHER

lead

Chinese University of Hong Kong

OTHER