Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System (NCT03214601) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System
United States30 participantsStarted 2017-12-04
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Anatomy that would require coverage of the brachiocephalic trunk (BCT) and/or left carotid arteries if a non-branch endograft were implanted
* At least one of the following:
a. Aneurysm of the ascending aorta, aortic arch, or proximal descending aorta that meets at least one of the following: i. ≥ 5.5 cm in diameter ii. ≥ 4.0 cm in diameter that has increased in size by 0.5 cm in the last 6 months iii. Measures twice the size of the normal aorta diameter iv. Is saccular in configuration
b. PAU within the ascending aorta, aortic arch, or proximal descending thoracic aorta (DTA) with or without intramural hematoma (IMH)
c. Chronic, uncomplicated aortic dissection distal to the BCT (type B), with either aortic diameter ≥5.5 cm or ≥4.0 cm with an increase in size by 0.5 cm in the last 6 months d. IMH distal to the BCT with recurrent symptoms, i.e. hypertension or intractable pain, despite best medical therapy.
* A non-aneurysmal proximal aortic neck diameter ranging between 28 mm and 43 mm and a non-aneurysmal distal aortic neck diameter ranging between 19 mm and 43 mm.
* A proximal attachment zone of the arch graft, meeting the oversizing requirement, must be a minimum of 25mm in length when measured on the inner curve of the ascending aorta, proximal to the BCT.
* Total length from the coronaries to the proximal edge of the BCT must be a minimum of 70mm.
* The length of the distal landing zone should be 20mm minimum.
* Coverage of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.