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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
7
Arteriovenous graft thrombectomy
University Health Network Toronto General
Toronto, Ontario, Canada
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
Time frame: Intraoperative
Safety Evaluation
Aggregated major adverse events of \< 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding)
Time frame: 24 Hours
Device Safety
Successful withdrawal of device along with clots without angiographically significant emboli, vessel trauma, entry site aneurysm, major bleeding complications
Time frame: Intraoperative
Technical Success
Ratio of successful thrombus removals and total number of participants
Time frame: Intraoperative
Thrombus Removal Rate
Percent of thrombus removal comparing pre-treatment to post-treatment angiography
Time frame: Post-procedure
30-Day Patency Rate
Patency of graft at 30-days post-procedure as assessed by ultrasound or other method
Time frame: 30-days
Clinical Success
Ability to deliver dialysis via the graft post procedure for at least one session
Time frame: Open
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