RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices … (NCT03207568) | Clinical Trial Compass
CompletedNot Applicable
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
30 participantsStarted 2014-10-25
Plain-language summary
The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic pathologies.
Clinical results will be used to apply for the CE certification.
Who can participate
Age range
18 Years – 85 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:
* Patient diagnosed with thoracic aorta pathology (aneurysm, pseudoaneurysm, dissection, penetrating ulcer or intramural hematoma) suitable for TEVAR with a Relay Pro or Relay NBS Pro stent-graft; diagnosis must be confirmed by contrast computed tomography angiography (CTA) or magnetic resonance imaging (MRI) within 3 months of the planned implant procedure.
* Proximal and distal aortic necks suitable for stent-graft placement (i.e., diameter ranging between 18 and 42 mm)
* Proximal and distal landing zones suitable for the stent-graft
* Adequate vascular access for insertion of the delivery system, i.e., femoral or iliac arteries a minimum 6 mm in diameter to accommodate the 19 to 22-Fr outer-diameter delivery system and no excessive disease precluding delivery system entry/passage or iliac arteries that could be extended via an access conduit.
* Written informed consent provided by the subject him/herself (not a representative) upon enrollment
Exclusion Criteria:
Patients who meet one or more of the following criteria are not eligible:
* Aneurysm/lesion location not accessible to the delivery system and stent placement
* Arterial access size insufficient for delivery system entrance or impossibility to perform a surgical access conduit
* Treatment of lesion that would require a delivery system with usable length greater than 90 cm
* Excessive arterial disease precluding delivery system entrance or passage
* Systemic infection
* Arterial tortuosity no…
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.
What they're measuring
1
Freedom from aneurysm or dissection-related mortality