AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

Study Overview
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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.

Official Title
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AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

Conditions
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Arteriovenous Graft Thrombosis

Intervention / Treatment
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* Device: CAPERE Thrombectomy System


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVATR-Toronto<br>Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System | Device: CAPERE Thrombectomy System<br>* Arteriovenous graft thrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint (Effectiveness) | Clearance of clot and restoration of blood flow within the affected graft as confirmed via angiographic endpoint in conjunction with a clinical or hemodynamic endpoint | Intraoperative | 
| Safety Evaluation | Aggregated major adverse events of < 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding) | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Safety | Successful withdrawal of device along with clots without angiographically significant emboli, vessel trauma, entry site aneurysm, major bleeding complications | Intraoperative | 
| Technical Success | Ratio of successful thrombus removals and total number of participants | Intraoperative | 
| Thrombus Removal Rate | Percent of thrombus removal comparing pre-treatment to post-treatment angiography | Post-procedure | 
| 30-Day Patency Rate | Patency of graft at 30-days post-procedure as assessed by ultrasound or other method | 30-days | 
| Clinical Success | Ability to deliver dialysis via the graft post procedure for at least one session | Open |