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NCT02813577 · ClinicalTrials.gov registry record · NA
Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
A NA study, sponsored by C. R. Bard.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT02813577: Clinical Trial NA study, sponsored by C. R. Bard.
NCT02813577 is a NA study that was terminated before completion, run by C. R. Bard. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02813577, a NA study, was terminated before completion, sponsored by C. R. Bard.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix® Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2) years.
Primary Outcome
Index limb amputation includes above or below the ankle amputations.
Interventions
- DEVICE Lutonix® 035 Drug Coated Balloon PTA Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-04-20 |
| Est. Completion | 2019-02-18 |
| Phase | NA |
Why NCT02813577 stopped before completion
NCT02813577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Lutonix® 035 Drug Coated Balloon PTA Catheter is the first listed.
NCT02813577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02813577 about?
NCT02813577 is a clinical study titled "Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)". The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix® Catheter. Subjects will have a Du...
What is the current status of trial NCT02813577?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2018-04-20. Estimated completion is 2019-02-18.
What interventions are being tested in trial NCT02813577?
The interventions under investigation include: Lutonix® 035 Drug Coated Balloon PTA Catheter (DEVICE).
Who is sponsoring clinical trial NCT02813577?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02813577's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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