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Drug Coated Balloon

IN.PACT AV DCB for Arteriovenous Fistula Occlusion

N/A

Waitlist Available

Led By Hiroaki Haruguchi, MD

Research Sponsored by Medtronic Endovascular

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 6, 9, 12, 18, 24, and 36 months

Awards & highlights

Study Summary

This trial is comparing the safety and effectiveness of the IN.PACT™ AV Access Drug Coated Balloon to percutaneous transluminal angioplasty for treatment of subjects with de novo or non-stented restenotic obstructive lesions of native arteriovenous dialysis fistulae in the upper extremity.

Eligible Conditions

Arteriovenous Fistula Occlusion
Arteriovenous Fistula
Arteriovenous Fistula Stenosis
Fistula

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 9, 12, 18, 24, and 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 9, 12, 18, 24, and 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 9, 12, 18, 24, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Safety Endpoint - Serious Adverse Event Rate

Target Lesion Primary Patency Rate Through 6 Months

Secondary outcome measures

Abandonment of Target AVF

Access Circuit Primary Patency

Clinical Success

+14 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IN.PACT AV DCBExperimental Treatment1 Intervention

PTA will be performed using the IN.PACT AV Access Drug Coated Balloon. IN.PACT AV Access DCB was the device name used during the clinical study. Medtronic has changed the name of the device to IN.PACT™ AV Paclitaxel-Coated Balloon Catheter (also referred as IN.PACT AV DCB). Hence, throughout posting, the study device will be referred to as the "IN.PACT AV DCB."

Group II: Standard Balloon AngioplastyActive Control1 Intervention

PTA will be performed using a commercially available uncoated PTA balloon.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IN.PACT AV DCB

2017

N/A

~330

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medtronic EndovascularLead Sponsor

68 Previous Clinical Trials

14,631 Total Patients Enrolled

Hiroaki Haruguchi, MDPrincipal InvestigatorHaruguchi Vascular Access Clinic

Andrew Holden, MDPrincipal InvestigatorAuckland City Hospital

12 Previous Clinical Trials

787 Total Patients Enrolled

Frequently Asked Questions

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

What is the aim of this medical experiment?

"The principal endpoint of this trial, measured during the 30 day period post-treatment, is Target Lesion Primary Patency Through 6 Months. Auxiliary objectives include Abandonment of Target AVF ( until 36 months after index procedure), Cumulative Access Circuit Thromboses (up to 24 months) and Device Success (defined as successful delivery, inflation, deflation and retrieval without burst or RBP)."

Answered by AI

Are there any vacancies on this clinical trial at present?

"According to clinicaltrials.gov, this trial has ended recruitment and was last modified on August 12th 2022. Nevertheless, there are still 110 other studies currently accepting participants for evaluation."

Answered by AI

Are there many US-based sites operating this experiment?

"This experiment has 21 recruitment sites, including the SKI Vascular Center in Tempe, University Surgical Associates in Chattanooga and Sentara Vascular Specialists in Norfolk."

Answered by AI