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NCT03506308 · ClinicalTrials.gov registry record · NA
Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae
A NA study of Arteriovenous Fistula, sponsored by C. R. Bard.
- Active
- Registry status
- NA
- Development phase
- 213
- Enrollment target
- 20
- Study locations
NCT03506308: Active NA study of Arteriovenous Fistula, sponsored by C. R. Bard.
NCT03506308 is a NA study of Arteriovenous Fistula that is active but no longer recruiting, run by C. R. Bard. The registered enrollment target is 213 participants, roughly in line with the 206-participant average among 8 other Arteriovenous Fistula trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03506308, a NA study of Arteriovenous Fistula, is active but no longer recruiting, sponsored by C. R. Bard.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 213 participants
- Enrollment target
- 20
- Study locations
Study 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 extremity.
Primary Outcome
TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.
Conditions Studied
Interventions
- DEVICE LUTONIX 035 Drug Coated Balloon PTA Catheter
Study Locations (20)
Texas
- Dallas Vascular Center - Dallas
- HCA Houston Healthcare - Houston
- Houston Methodist Hospital - Houston
Alabama
- University of Alabama at Birmingham - Birmingham
- Flowers Hospital - Dothan
California
- St. Joseph Hospital of Orange - Orange
- Kaiser Permanente - San Diego
Louisiana
- Ochsner Health System - New Orleans
- Ochsner Louisiana State University Health - Shreveport
New York
- Columbia University Medical Center - New York
- Rochester General Hospital - Rochester
Connecticut
- Yale University - New Haven
Iowa
- University of Iowa Hospital and Clinics - Iowa City
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2018-08-07 |
| Est. Completion | 2030-04 |
| Phase | NA |
What the registry record for NCT03506308 still lists
NCT03506308 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 206-participant average among 8 other Arteriovenous Fistula trials with a reported enrollment target.
The record links to 1 condition, with Arteriovenous Fistula appearing as the primary indexed condition, and to 1 intervention - of which LUTONIX 035 Drug Coated Balloon PTA Catheter is the first listed.
NCT03506308 names 20 study sites across 14 states, led by Texas, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT03506308 about?
NCT03506308 is a clinical study titled "Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous 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 ...
What is the current status of trial NCT03506308?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 213 participants. The study started on 2018-08-07. Estimated completion is 2030-04.
What conditions does trial NCT03506308 study?
This clinical trial studies the following conditions: Arteriovenous Fistula.
What interventions are being tested in trial NCT03506308?
The interventions under investigation include: LUTONIX 035 Drug Coated Balloon PTA Catheter (DEVICE).
Who is sponsoring clinical trial NCT03506308?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03506308 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Arteriovenous Fistula
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03506308's enrollment target sits among peer trials
213 5th of 8 higher than 4 of 8 other Arteriovenous Fistula trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arteriovenous Fistula trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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