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

Study Overview
=================
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.

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

Conditions
-----------------
Dysfunctional Arterial-venous Grafts

Intervention / Treatment
-----------------
* Device: Atherectomy and balloon angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Treatment of Jetstream™ atherectomy device and Ranger ™ drug coated balloons
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dysfunction AV graft<br>Dysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty | Device: Atherectomy and balloon angioplasty<br>* Atherectomy and balloon angioplasty of arterial-venous graft stenosis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Primary Patency (TLPP) through 6 months | 50% re-stenosis of the target lesion | within 6 months post intervention |