AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System (AVATR)

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 Overview

• Status: Terminated
• Conditions: Arteriovenous Graft Thrombosis
• Intervention / Treatment: Device: CAPERE Thrombectomy System

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • University Health Network Toronto General

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVATR-Toronto; Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System	Device: CAPERE Thrombectomy System; Arteriovenous graft thrombectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Sebastian Mafeld, MD, University Health Network Toronto General

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2020
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: TP19-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes