Arteriovenous Graft ThrombosisAVATRNCT04494035
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
A study testing CAPERE Thrombectomy System in people with Arteriovenous Graft Thrombosis, run by Medtronic Endovascular at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Graft Thrombosis
- What is being tested?
- CAPERE Thrombectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2020to 23 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network Toronto General
Toronto, Ontario, M5G 1Z5
About this study
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
- Being tested
- CAPERE Thrombectomy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPERE Thrombectomy SystemDevice
Arteriovenous graft thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| AVATR-Toronto | Experimental | Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System Receives: Device: CAPERE Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intraoperative
Safety Evaluation
Aggregated major adverse events of < 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding)
Measured: 24 Hours
Secondary outcomes (5)
Device Safety
Successful withdrawal of device along with clots without angiographically significant emboli, vessel trauma, entry site aneurysm, major bleeding complications
Measured: Intraoperative
Technical Success
Ratio of successful thrombus removals and total number of participants
Measured: Intraoperative
Thrombus Removal Rate
Percent of thrombus removal comparing pre-treatment to post-treatment angiography
Measured: Post-procedure
30-Day Patency Rate
Patency of graft at 30-days post-procedure as assessed by ultrasound or other method
Measured: 30-days
Clinical Success
Ability to deliver dialysis via the graft post procedure for at least one session
Measured: Open
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start14 Jan 2020
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Why it stopped: Sponsor change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Graft ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian Mafeld, MD, Principal investigator, University Health Network Toronto General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494035
- Sponsor's protocol ID
- TP19-0010
- Acronym
- AVATR
- Status last verified
- Sep 2022
- First submitted
- 22 Jul 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System
- ClinicalTrials.gov ID
- NCT04494035
- Acronym / sponsor ID
- AVATR / TP19-0010
- Conditions
- Arteriovenous Graft Thrombosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor change
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| AVATR-Toronto | Experimental | Device: CAPERE Thrombectomy SystemThrombectomy of arteriovenous graft using CAPERE Thrombectomy System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPERE Thrombectomy SystemArteriovenous graft thrombectomy | Device | AVATR-Toronto |
Primary outcome
Primary Endpoint (Effectiveness)
Time frame: 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
Time frame: 24 Hours
Aggregated major adverse events of < 5% (events that cannot be adjudicated in less than 24 hours: death, stroke, major bleeding)
5 secondary outcomes
Device Safety
Time frame: Intraoperative
Technical Success
Time frame: Intraoperative
Thrombus Removal Rate
Time frame: Post-procedure
30-Day Patency Rate
Time frame: 30-days
Clinical Success
Time frame: Open
Results and safety
The study was stopped early (reason given: Sponsor change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Arteriovenous Graft Thrombosis
RecruitingObservational study
Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis
Arteriovenous Graft Thrombosis, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Mafeld, MD principal investigator
University Health Network Toronto General
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPERE Thrombectomy System in people with Arteriovenous Graft Thrombosis, run by Medtronic Endovascular at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (Effectiveness) (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.