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RECRUITING
NCT07078383
NA

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

Sponsor: Vascutek Ltd.

View on ClinicalTrials.gov

Summary

The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta. This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels. The first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in a planned surgery. After the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in an emergency setting. Data will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.

Official title: Evaluation of the Rapidlink Device for Use in the Repair or Replacement of the Supra-Aortic Vessels During an Open Surgical Procedure of the Thoracic Aorta

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-12-19

Completion Date

2028-11

Last Updated

2026-02-06

Healthy Volunteers

No

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.

Locations (23)

Keck Medicine of USC

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

UF Health Shands Hospital

Gainesville, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Acension Seton Medical Center

Austin, Texas, United States

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States

Froedhert Hospital

Milwaukee, Wisconsin, United States

University Hospital Vienna

Vienna, Austria

University Medical Center Freiburg

Freiburg im Breisgau, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Robert Bosch Hospital

Stuttgart, Germany

Radboud University Medical Center

Nijmegen, Radboud, Netherlands

University Hospital of Bern

Bern, Switzerland

St Bartholomew's Hospital

London, United Kingdom