Back to resultsAVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System (AVATR)
Primary Purpose
Arteriovenous Graft Thrombosis
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CAPERE Thrombectomy System
Sponsored by
About this trial
This is an interventional device feasibility trial for Arteriovenous Graft Thrombosis
Eligibility Criteria
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
Sites / Locations
- University Health Network Toronto General
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AVATR-Toronto
Arm Description
Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System
Outcomes
Primary Outcome Measures
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
Safety Evaluation
Aggregated major adverse events of < 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding)
Secondary Outcome Measures
Device Safety
Successful withdrawal of device along with clots without angiographically significant emboli, vessel trauma, entry site aneurysm, major bleeding complications
Technical Success
Ratio of successful thrombus removals and total number of participants
Thrombus Removal Rate
Percent of thrombus removal comparing pre-treatment to post-treatment angiography
30-Day Patency Rate
Patency of graft at 30-days post-procedure as assessed by ultrasound or other method
Clinical Success
Ability to deliver dialysis via the graft post procedure for at least one session
Full Information
NCT ID
NCT04494035
First Posted
July 22, 2020
Last Updated
September 8, 2022
Sponsor
Medtronic Endovascular
1. Study Identification
Unique Protocol Identification Number
NCT04494035
Brief Title
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
Acronym
AVATR
Official Title
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor change
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Graft Thrombosis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AVATR-Toronto
Arm Type
Experimental
Arm Description
Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System
Intervention Type
Device
Intervention Name(s)
CAPERE Thrombectomy System
Intervention Description
Arteriovenous graft thrombectomy
Primary Outcome Measure Information:
Title
Primary Endpoint (Effectiveness)
Description
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
Title
Safety Evaluation
Description
Aggregated major adverse events of < 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding)
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Device Safety
Description
Successful withdrawal of device along with clots without angiographically significant emboli, vessel trauma, entry site aneurysm, major bleeding complications
Time Frame
Intraoperative
Title
Technical Success
Description
Ratio of successful thrombus removals and total number of participants
Time Frame
Intraoperative
Title
Thrombus Removal Rate
Description
Percent of thrombus removal comparing pre-treatment to post-treatment angiography
Time Frame
Post-procedure
Title
30-Day Patency Rate
Description
Patency of graft at 30-days post-procedure as assessed by ultrasound or other method
Time Frame
30-days
Title
Clinical Success
Description
Ability to deliver dialysis via the graft post procedure for at least one session
Time Frame
Open
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Mafeld, MD
Organizational Affiliation
University Health Network Toronto General
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network Toronto General
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
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