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

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.

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.