A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta

NANot yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2028

Conditions
Aortic AneurysmAortic Aneurysm and DissectionAortic DiseasesAneurysm of Aorta, ThoracicAneurysmal DiseaseAorta, Thoracic Pathologies
Interventions
DEVICE

Rapidlink

The Rapidlink implant is comprised of a Gelweave graft section (gelatin-sealed woven polyester) attached to a stented section (which utilizes nitinol ring stents), with a 'cuff'' feature joined to the stented section of the implant. The implant is supplied pre-loaded in a single use delivery system which compacts the stented section within a polytetrafluoroethylene (PTFE) sheath at the front of the system.

Trial Locations (23)

1090

University Hospital Vienna, Vienna

3010

University Hospital of Bern, Bern

15232

UPMC Presbyterian, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

20010

Medstar Washington Hospital Center, Washington D.C.

20246

University Medical Center Hamburg-Eppendorf, Hamburg

32608

UF Health Shands Hospital, Gainesville

33176

Baptist Hospital of Miami, Miami

33606

Tampa General Hospital, Tampa

53226

Froedhert Hospital, Milwaukee

55905

Mayo Clinic Rochester, Rochester

60611

Northwestern Memorial Hospital, Chicago

63110

Barnes-Jewish Hospital, St Louis

70376

Robert Bosch Hospital, Stuttgart

75093

Baylor Scott & White The Heart Hospital - Plano, Plano

78705

Acension Seton Medical Center, Austin

79106

University Medical Center Freiburg, Freiburg im Breisgau

80045

University of Colorado Anschutz Medical Campus, Aurora

90033

Keck Medicine of USC, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

02129

Massachusetts General Hospital, Boston

Unknown

Radboud University Medical Center, Nijmegen

EC1A 7BE

St Bartholomew's Hospital, London

All Listed Sponsors
lead

Vascutek Ltd.

INDUSTRY

NCT07078383 - A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta | Biotech Hunter | Biotech Hunter