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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.
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
Conditions
Interventions
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