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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 is a NA study that was terminated before completion, run by C. R. Bard. The registered enrollment target is 4 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02813577
The ClinicalTrials.gov registry entry for NCT02813577 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is C. R. Bard, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lutonix® 035 Drug Coated Balloon PTA Catheter is the first listed.
NCT02813577 reports 0 study locations.
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.
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