AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

Sponsors

Lead Sponsor: Vascular Medcure, Inc.

Source Vascular Medcure, Inc.
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.

Overall Status Recruiting
Start Date January 14, 2020
Completion Date February 1, 2021
Primary Completion Date December 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary Objective (restoration of blood flow/palpable continuous thrill) Intraoperative
Secondary Outcome
Measure Time Frame
Secondary Objective 1 (clear thrombus from graft) Intraoperative
Secondary Objective 2 (adverse events occurrence rate) Intraoperative
Enrollment 10
Condition
Intervention

Intervention Type: Device

Intervention Name: CAPERE Thrombectomy System

Description: Arteriovenous graft thrombectomy

Arm Group Label: AVATR-Toronto

Eligibility

Criteria:

Inclusion Criteria:

- Dialysis patients who are > 18 years of age

- Dialysis patients with clinical signs, symptoms and presentation consistent with acute thrombosis in their AV graft; 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Sebastian Mafeld, MD Principal Investigator UHN
Overall Contact

Last Name: Jeffrey P DuMontelle

Phone: 7149150886

Email: [email protected]

Location
Facility: Status: Contact: Investigator: University Health Network Toronto General Sebastian Mafeld, MD [email protected] Sebastian Mafeld, MD Principal Investigator Dheeraj Rajan, MD Principal Investigator
Location Countries

Canada

Verification Date

July 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: AVATR-Toronto

Type: Experimental

Description: Thrombectomy of arteriovenous graft using CAPERE Thrombectomy System

Acronym AVATR
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention 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.

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov