AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System (NCT04494035) | Clinical Trial Compass
TerminatedNot Applicable
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
Stopped: Sponsor change
Canada7 participantsStarted 2020-01-14
Plain-language summary
A prospective, single-arm, non-blinded study, intending to treat and collect and evaluate data in up to ten (10) human subjects who are currently being treated with hemodialysis and who present with acute thrombosis in their arteriovenous (AV) grafts, treated with the CAPERE® Thrombectomy System.
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:
* Dialysis patients who are ≥ 18 years of age
* Dialysis patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms ≤ 14 days
Exclusion Criteria:
* Dialysis patients who are ≤ 18 years of age.
* Grafts with aneurysmal degeneration
* Central venous occlusion
* Patients with infection of the vascular access
* Patients with active cancer under current therapy, myeloproliferative syndromes, hyperhomocysteinemia, and heparin-induced thrombocytopenia.
* Patients with pulmonary embolism (PE) with hemodynamic compromise
* Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
* Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated
* Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention (e.g. recent access site creation where there are concerns of leak or disruption of the suture line)
* Female who is pregnant or nursing
* Concurrent participation in another investigational drug or device treatment 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.