AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

NCT04494035 | Terminated DMC FDA Device

• 1 other identifier: TP19-0010
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Graft Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Device Safety

  Intraoperative

• Technical Success

  Intraoperative

• Thrombus Removal Rate

  Post-procedure

• 30-Day Patency Rate

  30-days

• Clinical Success

  Open

Study Arms (1)

AVATR-Toronto

EXPERIMENTAL

Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System

Device: CAPERE Thrombectomy System

Interventions

CAPERE Thrombectomy System DEVICE

Arteriovenous graft thrombectomy

AVATR-Toronto

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (1)

University Health Network Toronto General

Toronto, Ontario, M5G 1Z5, Canada

Location

Study Officials

• Sebastian Mafeld, MD

  University Health Network Toronto General

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 22, 2020
• First Posted: July 31, 2020
• Study Start: January 14, 2020
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)