Arteriovenous Graft Thrombosis
Conditions
Brief 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.
Interventions
Arteriovenous graft thrombectomy
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint (Effectiveness) | Intraoperative | 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 |
| Safety Evaluation | 24 Hours | Aggregated major adverse events of \< 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombus Removal Rate | Post-procedure | Percent of thrombus removal comparing pre-treatment to post-treatment angiography |
| Device Safety | Intraoperative | Successful withdrawal of device along with clots without angiographically significant emboli, vessel trauma, entry site aneurysm, major bleeding complications |
| Clinical Success | Open | Ability to deliver dialysis via the graft post procedure for at least one session |
| 30-Day Patency Rate | 30-days | Patency of graft at 30-days post-procedure as assessed by ultrasound or other method |
| Technical Success | Intraoperative | Ratio of successful thrombus removals and total number of participants |
Countries
Canada
Outcome results
None listed