Overview
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.
Eligibility
Inclusion Criteria:
- Dialysis patients who are > 18 years of age
- Dialysis patients with clinical signs, symptoms and presentation consistent with acute thrombosis in their AV graft; 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 pretreated
- 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