AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

Arteriovenous Graft Thrombosis Clinical Trial

— AVATR  

Official title:

AVATR - Arteriovenous Access Thrombosis Removal With CAPERE Thrombectomy System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04494035
• Other study ID #: TP19-0010
• Status: Terminated
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: October 23, 2020

Study information

• Verified date: September 2022
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Graft Thrombosis
• Thrombosis

Intervention

Device:
• CAPERE Thrombectomy System
Arteriovenous graft thrombectomy

Locations

Country	Name	City	State
Canada	University Health Network Toronto General	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Device Safety	Successful withdrawal of device along with clots without angiographically significant emboli, vessel trauma, entry site aneurysm, major bleeding complications	Intraoperative
Secondary	Technical Success	Ratio of successful thrombus removals and total number of participants	Intraoperative
Secondary	Thrombus Removal Rate	Percent of thrombus removal comparing pre-treatment to post-treatment angiography	Post-procedure
Secondary	30-Day Patency Rate	Patency of graft at 30-days post-procedure as assessed by ultrasound or other method	30-days
Secondary	Clinical Success	Ability to deliver dialysis via the graft post procedure for at least one session	Open