Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System (NCT03214601)
A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery
๐ฉบ Plain-English Summary (8th-Grade Level)
The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.
Who can join: Review the eligibility criteria below.
Location: University of Southern California โ Los Angeles, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (12 Sites)
- University of Southern California โ Los Angeles, California
- University of Florida โ Gainesville, Florida
- Emory University โ Atlanta, Georgia
- University of Maryland โ Baltimore, Maryland
- Massachusetts General Hospital โ Boston, Massachusetts
- Barnes Jewish Hospital at Washington University โ St Louis, Missouri
- Columbia University Medical Center โ New York, New York
- Duke University โ Durham, North Carolina
- Cleveland Clinic โ Cleveland, Ohio
- Hospital of the University of Pennsylvania/Penn Presbyterian โ Philadelphia, Pennsylvania
- Baylor College of Medicine โ Houston, Texas
- Baylor Scott and White Research Institute โ Plano, Texas
๐ฐ 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 ยง 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.
Explore by condition: All Thoracic Aorta Aneurysm clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.