AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

Medtronic

Status

Terminated

Conditions

Arteriovenous Graft Thrombosis

Treatments

Device: CAPERE Thrombectomy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04494035

TP19-0010

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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