Active — Not RecruitingNot Applicable

RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

United States, Japan110 participantsStarted 2017-05-10

Plain-language summary

Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.

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: * Subject must be ≥ 18 years of age * Subject has specified disease in his/her descending thoracic aorta. * Subject have anatomical compliance for the device specified for both access vessels and treatment area. * Subject must be willing to comply with the follow-up evaluation schedule. * Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment. Exclusion Criteria: * Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm. * Subject anatomy with significant stenosis, calcification, thrombus or tortuosity. * Subjects with specified compromised circulation. * Subjects with specified prior procedures. * Subjects with allergy to contrast media or device components. * Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure. * Subjects that are pregnant or planning to become pregnant during the course of the study.

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

Rate of Major Adverse Events (MAEs)

Timeframe: 30 days

Technical success

Timeframe: 24 hours

Stent graft patency

Timeframe: 12 months

Aneurysm rupture

Timeframe: 12 months

Absence of Type I and III endoleak through 12 months;

Timeframe: 12 months

Absence of stent fractures in the attachment zone through 12 months

Timeframe: 12 months

Absence of open or endovascular secondary interventions

Timeframe: 12 months

Absence of aneurysm expansion (> 5 mm diameter increase)

Timeframe: 12 months

Trial details

NCT IDNCT02818972

SponsorBolton Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-24

View on ClinicalTrials.gov More Aortic Aneurysm, Thoracic trials

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.

What they're measuring

Rate of Major Adverse Events (MAEs)

Timeframe: 30 days

Technical success

Timeframe: 24 hours

Stent graft patency

Timeframe: 12 months

Aneurysm rupture

Timeframe: 12 months

Absence of Type I and III endoleak through 12 months;

Timeframe: 12 months

Absence of stent fractures in the attachment zone through 12 months

Timeframe: 12 months

Absence of open or endovascular secondary interventions

Timeframe: 12 months

Absence of aneurysm expansion (> 5 mm diameter increase)

Timeframe: 12 months