Your session is about to expire
← Back to Search
Drug-Coated Balloon for Arteriovenous Fistula (AVPAS Trial)
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.
AVPAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAVPAS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AVPAS Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I haven't had surgery at the procedure site in the last 30 days.My arm's blood vessel connection needs imaging due to issues.My lesion can be treated with a specific device according to its usage guide.I am an adult over 18 and not pregnant or breastfeeding.You have an allergy to contrast dye that cannot be controlled.My target lesion is near the center of my shoulder area.The area being studied is inside a metal stent.I had a clot in my dialysis access treated within the last week.My AV fistula has a narrowing in the vein from where it's connected to near my shoulder.My artery was successfully widened without major issues using a special balloon.
- Group 1: LUTONIX 035 Drug Coated Balloon PTA Catheter
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
Share this study with friends
Copy Link
Messenger