NCT04627051

Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis

A Prospective, Single-Centre Study Investigating the Clinical Use and Safety of the Jetstream Atherectomy With Drug Coated Balloon (Ranger) for the Treatment of Dysfunctional Arterio-Venous Graft Stenosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-centre, single-arm, prospective study will enroll 30 subjects presenting with clinical and hemodynamic abnormalities in arteriovenous graft (AVG) in the arm. Subjects will be treated with the Jetstream™ atherectomy device and Ranger™ Drug Coated Balloons (DCB). Subjects will be followed up clinically via office visit or phone visit at 6 and 12 months post procedure. This study is to demonstrate safety and assess the clinical use and outcomes of the Jetstream ™atherectomy device and Ranger™ DCB for the treatment of dysfunctional AV graft.

Conditions

• Dysfunctional Arterial-venous Grafts

Interventions

Type	Name	Description
DEVICE	Atherectomy and balloon angioplasty	Atherectomy and balloon angioplasty of arterial-venous graft stenosis

Timeline

• Start date: 2020-11-12
• Primary completion: 2021-12-01
• Completion: 2023-01-01
• First posted: 2020-11-13
• Last updated: 2021-03-12

Locations

1 site across 1 country: Canada