AzTrials
AzTrials

Arteriovenous FistulaAVPASNCT03506308

Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

A study testing LUTONIX 035 Drug Coated Balloon PTA Catheter in people with Arteriovenous Fistula, run by C. R. Bard at 26 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arteriovenous Fistula
What is being tested?
LUTONIX 035 Drug Coated Balloon PTA Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
26 sitesin 2 countries
Study dates
7 Aug 2018to Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or non-pregnant, non-breastfeeding female ≥18 years of age
  • Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
  • 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)
  • Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein
  • Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:
Show all 10Show fewer
  • No clinically significant dissection;
  • No extravasation requiring treatment;
  • Residual stenosis ≤30% by angiographic measurement;
  • Ability to completely efface the waist using the pre-dilation balloon.

Who cannot join

  • Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
  • Subject has a non-controllable allergy to contrast
  • Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up
  • Target lesion is located central to the axillosubclavian junction
  • A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
  • Prior surgical interventions of the access site ≤30 days before the index procedure
  • Target lesion is located within a bare metal or covered stent

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States22 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • MedStar Health Research Institute

    Annapolis, Maryland, 21401

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dallas Vascular Center

    Dallas, Texas, 75208

  • Flowers Hospital

    Dothan, Alabama, 36305

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • HCA Houston Healthcare

    Houston, Texas, 77004

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Texas Health Science Center

    Houston, Texas, 77030

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale University

    New Haven, Connecticut, 06520

  • Ochsner Health System

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Sentara Medical Group

    Norfolk, Virginia, 23507

  • St. Joseph Hospital of Orange

    Orange, California, 92868

  • Rochester General Hospital

    Rochester, New York, 14621

  • Kaiser Permanente

    San Diego, California, 92123

  • Ochsner Louisiana State University Health

    Shreveport, Louisiana, 71103

Other trials in United States

Canada4 sites

  • William Osler Health System/Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Centre hospitalier de l'Université de Montreal

    Montreal, Quebec, H2X 0C1

  • Scarborough Health Network

    Scarborough Village, Ontario, M1P 2V5

  • University Health Network

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

About this study

Official title: A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Read the detailed description

This post-market approval study (PAS) is required by the FDA as a condition of approval for the Lutonix drug coated balloon catheter. It is intended to demonstrate safety and assess the clinical use and outcomes of the LUTONIX Catheter in dysfunctional arteriovenous fistulae (AVF) in a heterogeneous patient population in real world clinical practice.

Being tested
LUTONIX 035 Drug Coated Balloon PTA Catheter
Medical subject headings
Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LUTONIX 035 Drug Coated Balloon PTA CatheterDevice

    All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Study groups in NCT03506308
Study groupRoleWhat they receive
LUTONIX 035 Drug Coated Balloon PTA CatheterOtherThis is a single-arm study. All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Receives: Device: LUTONIX 035 Drug Coated Balloon PTA Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Target Lesion Primary Patency (TLPP)

    TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.

    Measured: 6 Months

  2. Percentage of Participants With No Primary Safety Events

    Primary safety events include any serious adverse event(s) involving the AV access circuit through 30 days

    Measured: 30 days

Secondary outcomes (10)

  1. Percentage of Participants With Target Lesion Primary Patency

    TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.

    Measured: 12, 18, 24 Months

  2. Number of re-interventions required to maintain target lesion patency

    Clinically driven reintervention is defined as a lesion that has ≥ 50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines.

    Measured: 6, 12, 18, 24 Months

  3. Percentage of Participants With Access Circuit Primary Patency (ACPP)

    Access circuit is defined as the area from the AV access anastomosis to the superior vena cava-right atrial junction.

    Measured: 6, 12, 18, 24 Months

  4. Number of re-interventions required to maintain access circuit patency

    Clinically driven reintervention is defined as a lesion that has ≥ 50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines.

    Measured: 6, 12, 18, 24 Months

  5. Percentage of Participants With Device, Procedural, and Clinical Success

    Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure.

    Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs).

    Clinical Success: The resumption of dialysis for at least one session after the index procedure.

    Measured: 24 Months

  6. Percentage of Participants With Abandonment of Permanent Access in the Index Extremity

    The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.

    Measured: 6, 12, 18, 24 Months

  7. Percentage of Participants With Secondary Patency of the Access Circuit

    Survival of patency of access circuit from the time of intervention until access abandonment or achievement of a censored event (death, transfer to another hemodialysis unit, transfer to peritoneal dialysis, transplantation, and end of study period), and includes all surgical and endovascular interventions.

    Measured: 6, 12, 18, 24 Months

  8. Time to loss of target lesion secondary patency following DCB intervention

    Time between first reintervention with the DCB to the next loss of patency

    Measured: 24 Months

  9. Percentage of Participants With Freedom from any Serious Adverse Event(s) Involving the AV Access Circuit

    Safety events include any serious adverse event(s) involving the AV access circuit

    Measured: 6, 12, 18, 24 Months

  10. Percentage of Participants With Device and Procedure Related Adverse Events

    Freedom from device-related or procedure-related serious adverse events

    Measured: 6, 12, 18, 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2018
  2. Study start7 Aug 2018
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
213 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03506308
Sponsor's protocol ID
CL0033-01
Acronym
AVPAS
Status last verified
Mar 2026
First submitted
14 Apr 2018
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing LUTONIX 035 Drug Coated Balloon PTA Catheter in people with Arteriovenous Fistula, run by C. R. Bard at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Target Lesion Primary Patency (TLPP) (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03506308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in