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

Dysfunctional Arterial-venous Grafts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627051
• Other study ID #: 20-5673
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: January 2023

Study information

• Verified date: November 2020
• Source: University Health Network, Toronto
• Contact: Kong Teng Tan, MD
• Phone: 416-340-4800
• Email: kongteng.tan[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or non-pregnant, non-breastfeeding female =18 years of age;

• Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;

• Target lesion must be a mature arteriovenous graft presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines;

• Subject has a target lesion at the venous anastomosis of the AVG;

• Successful crossing of the stenosis;

• Each lesion length is =20mm, which may include tandem lesions that are =20mm apart

Exclusion Criteria:

• Subject is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this study;

• Subject has a non-controllable allergy to contrast;

• Subject has more than 3 lesions in the access circuit requiring intervention;

• Target lesion diameter >10mm;

• A thrombosed access or an access with a thrombosis treated =30 days prior to the index procedure;

• Prior surgical interventions of the access site =30 days before the index procedure;

• Target lesion is located within a bare metal or covered stent.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Dysfunctional Arterial-venous Grafts

Intervention

Device:
• Atherectomy and balloon angioplasty
Atherectomy and balloon angioplasty of arterial-venous graft stenosis

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Primary Patency (TLPP) through 6 months	50% re-stenosis of the target lesion	within 6 months post intervention