NCT04627051UnknownNot Applicable
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
University Health Network, Toronto2 sites in 1 country30 target enrollmentStarted: November 12, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Target Lesion Primary Patency (TLPP) through 6 months
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Target Lesion Primary Patency (TLPP) through 6 months
Time Frame: within 6 months post intervention
50% re-stenosis of the target lesion
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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