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 (NCT07078383)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Keck Medicine of USC — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (21 Sites)
- Keck Medicine of USC — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- Medstar Washington Hospital Center — Washington D.C., District of Columbia
- UF Health Shands Hospital — Gainesville, Florida
- Tampa General Hospital — Tampa, Florida
- Northwestern Memorial Hospital — Chicago, Illinois
- Johns Hopkins Hospital — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Barnes-Jewish Hospital — St Louis, Missouri
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
- UPMC Presbyterian — Pittsburgh, Pennsylvania
- Acension Seton Medical Center — Austin, Texas
- Baylor Scott & White The Heart Hospital - Plano — Plano, Texas
- Froedhert Hospital — Milwaukee, Wisconsin
- University Hospital Vienna — Vienna,
- University Medical Center Freiburg — Freiburg im Breisgau,
- University Medical Center Hamburg-Eppendorf — Hamburg,
- Robert Bosch Hospital — Stuttgart,
- Radboud University Medical Center — Nijmegen, Radboud
- St Bartholomew's Hospital — London,
📞 Contact the Study Coordinator
Phone: +441413430333
Email: s.macluskie@terumoaortic.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.