Dysfunctional Arterial-venous Grafts
Conditions
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.
Interventions
DEVICEAtherectomy and balloon angioplasty
Atherectomy and balloon angioplasty of arterial-venous graft stenosis
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Treatment of Jetstream™ atherectomy device and Ranger ™ drug coated balloons
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Primary Patency (TLPP) through 6 months | within 6 months post intervention | 50% re-stenosis of the target lesion |
Countries
Canada
Contacts
Primary ContactKong Teng Tan, MD
Outcome results
None listed