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Atherectomy Device
Atherectomy and balloon angioplasty for Arteriovenous Graft
N/A
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months post intervention
Awards & highlights
Study Summary
This trial will study 30 people with AV grafts in their arms who are experiencing clinical and hemodynamic abnormalities. Subjects will be treated with the Jetstream atherectomy device and Ranger Drug Coated Balloons. Follow up visits will occur at 6 and 12 months post procedure. The study's purpose 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 grafts.
Eligible Conditions
- Arteriovenous Graft
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 6 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Target Lesion Primary Patency (TLPP) through 6 months
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dysfunction AV graftExperimental Treatment1 Intervention
Dysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,387 Total Patients Enrolled
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