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Drug Coated Balloon

Drug-Coated Balloon for Arteriovenous Fistula (AVPAS Trial)

N/A
Recruiting
Led By Scott Trerotola, MD
Research Sponsored by C. R. Bard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines
Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 18, 24 months
Awards & highlights

AVPAS Trial Summary

This trial will study the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects with upper extremity AV fistulae.

Who is the study for?
This trial is for adults over 18 with a mature arteriovenous fistula in the arm that needs treatment based on specific guidelines. Participants must be able to give informed consent and follow the study's visit schedule. They can't join if they have other conditions affecting data or life expectancy, recent surgeries at the site, stents in place, are in another study, have severe contrast allergies, or had a thrombosis treated recently.Check my eligibility
What is being tested?
The Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter is being tested for safety and effectiveness in treating dysfunctional arteriovenous fistulas located in the upper extremity. This global study involves one group of participants who will all receive this particular treatment following successful pre-dilation of their lesion.See study design
What are the potential side effects?
Possible side effects may include reactions related to balloon angioplasty such as pain at the access site, bleeding or bruising, blood vessel damage, infection risk at the catheter insertion point and potential allergic reactions to materials used.

AVPAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My arm's blood vessel connection needs imaging due to issues.
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My lesion can be treated with a specific device according to its usage guide.
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I am an adult over 18 and not pregnant or breastfeeding.
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My AV fistula has a narrowing in the vein from where it's connected to near my shoulder.
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My artery was successfully widened without major issues using a special balloon.

AVPAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 18, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 18, 24 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
Percentage of Participants With No Primary Safety Events
Percentage of Participants With Target Lesion Primary Patency (TLPP)
Secondary outcome measures
Number of re-interventions required to maintain access circuit patency
Number of re-interventions required to maintain target lesion patency
Percentage of Participants With Abandonment of Permanent Access in the Index Extremity
+7 more
Other outcome measures
Vital status of participants

AVPAS Trial Design

1Treatment groups
Experimental Treatment
Group I: LUTONIX 035 Drug Coated Balloon PTA CatheterExperimental Treatment1 Intervention
This is a single-arm study. All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Find a Location

Who is running the clinical trial?

C. R. BardLead Sponsor
103 Previous Clinical Trials
39,252 Total Patients Enrolled
6 Trials studying Arteriovenous Fistula
999 Patients Enrolled for Arteriovenous Fistula
Scott Trerotola, MDPrincipal InvestigatorHospital of the University of Pennsylvania; Division of Interventional Radiology
1 Previous Clinical Trials
285 Total Patients Enrolled
1 Trials studying Arteriovenous Fistula
285 Patients Enrolled for Arteriovenous Fistula
Dheeraj Rajan, MDPrincipal InvestigatorUniversity Health Network; Division of Vascular & Interventional Radiology
3 Previous Clinical Trials
550 Total Patients Enrolled

Media Library

Lutonix® 035 AV Drug Coated Balloon (Drug Coated Balloon) Clinical Trial Eligibility Overview. Trial Name: NCT03506308 — N/A
Arteriovenous Fistula Research Study Groups: LUTONIX 035 Drug Coated Balloon PTA Catheter
Arteriovenous Fistula Clinical Trial 2023: Lutonix® 035 AV Drug Coated Balloon Highlights & Side Effects. Trial Name: NCT03506308 — N/A
Lutonix® 035 AV Drug Coated Balloon (Drug Coated Balloon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03506308 — N/A

Frequently Asked Questions

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

How many individuals are being included in this clinical research?

"Affirmative. Records on clinicaltrials.gov indicate that this investigation is presently recruiting subjects, beginning with the August 7th 2018 post and most recently updated on April 26th 2022. A total of 213 individuals are needed to participate in 15 locations across the country."

Answered by AI

What goals are investigators hoping to accomplish through this research endeavor?

"The primary outcome measure of this medical trial, as outlined by C. R. Bard, the sponsor of the study, is Percentage of Participants With No Primary Safety Events over a 6 Month period. Additionally, other secondary outcomes that will be recorded include Number of re-interventions required to maintain target lesion patency; Percentage of Participants With Access Circuit Primary Patency (ACPP); and Percentage of Participants With Secondary Patency of the Access Circuit which includes all surgical and endovascular interventions until access abandonment or cessation events such as death occurs."

Answered by AI

Can any new participants still join this research endeavor?

"The details listed on clinicaltrials.gov confirm that this experiment is actively recruiting individuals; it was first posted on August 7th 2018 and most recently edited April 26th 2022."

Answered by AI

Are there any Canadian healthcare institutions currently conducting this research study?

"The trial requires the enrollment of 15 individuals, and potential sites include Flowers Hospital in Dothan, University of Iowa Hospital and Clinics in Iowa City, Louisiana State University in Shreveport, as well as a dozen other locales."

Answered by AI
~30 spots leftby Mar 2025