AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2020-10-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Arteriovenous Graft Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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AVATR-Toronto

Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System

Group Type EXPERIMENTAL

CAPERE Thrombectomy System

Intervention Type DEVICE

Arteriovenous graft thrombectomy

Interventions

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CAPERE Thrombectomy System

Arteriovenous graft thrombectomy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No