AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    Vascular Medcure, Inc.
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Updated on 5 August 2020
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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.

Details
Condition Arteriovenous Graft Thrombosis
Age 18years - 100years
Treatment CAPERE Thrombectomy System
Clinical Study IdentifierNCT04494035
SponsorVascular Medcure, Inc.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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