The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry (NCT03966521) | Clinical Trial Compass
CompletedNot Applicable
The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry
United Kingdom105 participantsStarted 2019-06-26
Plain-language summary
The purpose of the BSET-CLEVAR Registry is to collect device-specific performance outcomes of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (EXCC device) in routine clinical treatment of patients with abdominal aortic aneurysm in the UK.
The novel EXCC device is an evolution of an established device allowing active shaping to conform to the specific patient aortic neck anatomy, with more accurate deployment, potentially greater neck coverage and better long term fixation/sealing. This may translate to improved effectiveness of this device over time, reducing the need for any further procedures. The primary aim of this study is to assess the degree of neck coverage by the EXCC device.
The British Society of Endovascular Therapy (BSET) has received funds from the stent manufacturer (W.L. Gore \& Associates, Inc.) to conduct this study. BSET and the Sponsor (Imperial College London) have full responsibility for the design, conduct, analysis and reporting of the study.
Who can participate
Age range
55 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:
The patient is / has:
* Age 55 or more at the time of informed consent signature.
* Non-ruptured infra-renal AAA that requires treatment, and in the opinion of the Investigator, whose anatomy is adequate to receive or has already received the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (EXCC device).
* A signed and dated Informed Consent Form signed by the patient either before or within 30 days of EXCC device implantation
Exclusion Criteria:
The patient is / has:
* Previous infra-renal aortic surgery
* Been treated in another aortic or thoracic medical device study within 1 year of study enrollment.
* Active infection
* Penetrating aortic ulcer or dissection or intramural haematoma in the treated segment
* Any clinically significant medical condition, which in the opinion of the investigator, may interfere with the study results or reduce life expectancy to \<2 years
* In the opinion of the investigator unable or unwilling to comply with the requirements 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
1
Endograft positioning accuracy and aortic neck coverage expressed as percentage of the total aortic neck assessed by CT images
Timeframe: between 4 weeks and 3 months following EVAR