AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

Not Applicable

Terminated

• Conditions: Arteriovenous Graft Thrombosis
• Interventions: Device: CAPERE Thrombectomy System

• Registration Number: NCT04494035
• Lead Sponsor: Medtronic Endovascular

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-07-31
• Primary Completion: 2020-10-23
• Study Completion: 2020-10-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AVATR-Toronto	CAPERE Thrombectomy System	Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University Health Network Toronto General; 🇨🇦 Toronto, Ontario, Canada