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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months post intervention for reporting.

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

1,471 Previous Clinical Trials

484,940 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are opportunities for patient participation in this experiment available at present?

"Affirmative. Clinicaltrials.gov points to this trial's indubitable recruitment status, which began on November 12th 2020 and was last updated on March 10 2021. In order to reach completion, 30 participants must enroll in the single centre running this experiment."

Answered by AI

To what extent has recruitment been successful for this clinical trial?

"Affirmative. Clinicaltrials.gov reports that this research is actively calling for volunteers, having first been advertised on November 12th 2020 and last updated March 10th 2021. The investigators require a total of 30 participants from one medical site to participate in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04627051.