SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis
Germany12 participantsStarted 2022-03-17
Plain-language summary
The purpose of this exploratory study is to evaluate safety and effectiveness of treatment of juxta-anastomotic (re)stenosis with SUPERA stent by improving hemodynamic situation through obtuse shaping of the anastomosis.
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
. Patients must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy \> 12 months.
. Hemodialysis patients undergoing endovascular angioplasty due to a clinically symptomatic stenosis (de novo or restenosis) of the juxta-anastomotic radiocephalic AVF with significant stenosis (lumen diameter \< 2.7mm)
. Patients with at least one previous endovascular intervention to restore AVF function
. The target lesion consists of one or more lesions with a target lesion length of less than or equal to 80 mm in the juxta-anastomotic segment of the radiocephalic AVF
. The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation)
. If there are other non-target lesions, then non-target lesions must be successfully cured with a balloon before treating the target lesion
Exclusion criteria
. Patients with AVF stenosis observed and estimated as nonsignificant (lumen diameter \> 2.7mm) or a vessel \<4.0 and \> 7.5 mm in diameter by visual estimation
. Patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated.
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
Number of patients with primary patency of juxta-anastomose at month 3
. Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
. Patients that are currently participating in another clinical trial involving any investigational drug or device that may potentially confound the results of the study, or that would limit the patient's compliance with the follow-up requirements of the study.
. Prior enrolment in this trial
. Women who are pregnant or lactating
. Patients, who underwent a major surgery (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study.
. Patients, who have scheduled a major surgery (such as thoracotomy, craniotomy, etc.). within 30 days after enrolment -