AVATR - Arteriovenous Access Thrombosis Removal With CAPE... | NCT04494035

Studies
AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

NCT04494035

Sponsor

Medtronic Endovascular

Status

Terminated

Last Update Posted

Sep 13, 2022Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Arteriovenous Graft Thrombosis

Interventions

CAPERE Thrombectomy System

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor change

Expanded Access Info

Start Date

Jan 14, 2020Actual

Primary Completion Date

Oct 23, 2020Actual

Completion Date

Oct 23, 2020Actual

First Submitted Date

Jul 22, 2020

First Submission Date that Met QC Criteria

Jul 30, 2020

First Posted Date

Jul 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2022

Last Update Posted Date

Sep 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AVATR-Toronto	Experimental	Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System	Device: CAPERE Thrombectomy System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAPERE Thrombectomy System	Device	Arteriovenous graft thrombectomy	AVATR-Toronto

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastian Mafeld, MD	University Health Network Toronto General	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network Toronto General		Toronto	Ontario	M5G 1Z5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description