Status:
TERMINATED
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
Lead Sponsor:
Medtronic Endovascular
Conditions:
Arteriovenous Graft Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04494035
Start Date
January 14 2020
End Date
October 23 2020
Last Update
September 13 2022
Active Locations (1)
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1
University Health Network Toronto General
Toronto, Ontario, Canada, M5G 1Z5