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

Not Applicable

• Conditions: Dysfunctional Arterial-venous Grafts
• Interventions: Device: Atherectomy and balloon angioplasty

• Registration Number: NCT04627051
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study Start: 2020-11-12
• Study First Posted: 2020-11-13
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-12
• Primary Completion: 2021-12
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dysfunction AV graft	Atherectomy and balloon angioplasty	Dysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty

Primary Outcome Measures

Name	Time	Method
Target Lesion Primary Patency (TLPP) through 6 months	within 6 months post intervention	50% re-stenosis of the target lesion

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada