Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae
Public ClinicalTrials.gov record NCT03506308. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03506308
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 213 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 7, 2018 (Actual)
- Primary completion
- Apr 2027 (Estimated)
- Completion
- Apr 2030 (Estimated)
- Last update posted
- Mar 18, 2026
2018 – 2030
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Flowers Hospital | Dothan | Alabama | 36305 | — |
| St. Joseph Hospital of Orange | Orange | California | 92868 | — |
| Kaiser Permanente | San Diego | California | 92123 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Ochsner Health System | New Orleans | Louisiana | 70121 | — |
| Ochsner Louisiana State University Health | Shreveport | Louisiana | 71103 | — |
| MedStar Health Research Institute | Annapolis | Maryland | 21401 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Rochester General Hospital | Rochester | New York | 14621 | — |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Dallas Vascular Center | Dallas | Texas | 75208 | — |
| HCA Houston Healthcare | Houston | Texas | 77004 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| University of Texas Health Science Center | Houston | Texas | 77030 | — |
| Sentara Medical Group | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03506308, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 18, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03506308 live on ClinicalTrials.gov.