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NCT01870401 · ClinicalTrials.gov registry record · NA
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
A NA study of Critical Limb Ischemia, sponsored by C. R. Bard.
- Completed
- Registry status
- NA
- Development phase
- 442
- Enrollment target
- 20
- Study locations
NCT01870401 is a NA study of Critical Limb Ischemia that has completed, run by C. R. Bard. The registered enrollment target is 442 participants, above the 67-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (560% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT01870401, a NA study of Critical Limb Ischemia, has completed, sponsored by C. R. Bard.
- COMPLETED
- Registry status
- NA
- Development phase
- 442 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
Conditions Studied
Interventions
- DEVICE Lutonix DCB
- DEVICE Uncoated PTA Catheter
Study Locations (20)
Florida
- Cardiovascular Solutions Institute, LLC - Bradenton
- Morton Plant Mease Health Care, Inc - Clearwater
- Cardiovascular Research of North Florida, LLC - Gainesville
- University of Florida - Gainesville
- Radiology and Imaging Specialists of Lakeland, P.A - Lakeland
- Mt. Sinai Medical Center - Miami Beach
Massachusetts
- Steward St. Elizabeth Medical Center of Boston - Boston
- Beth Israel Deaconess Medical Center - Boston
New Jersey
- Deborah Heart & Lung Ctr - Browns Mills
- Holy Name Medical Center - Teaneck
Connecticut
- Yale University-Yale New Haven Hospital - New Haven
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Illinois
- Prairie Education and Research Cooperative - Springfield
Iowa
- Central Iowa Hospital Corporation - West Des Moines
Louisiana
- CIS Clinical Research Corporation - Houma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2013-06-03 |
| Est. Completion | 2021-06-22 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01870401
The ClinicalTrials.gov registry entry for NCT01870401 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 442 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 67-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (560% higher). The listed sponsor is C. R. Bard, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Critical Limb Ischemia appearing as the primary indexed condition, and to 2 interventions - of which Lutonix DCB is the first listed.
NCT01870401 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Massachusetts, New Jersey.
Frequently Asked Questions
What is clinical trial NCT01870401 about?
NCT01870401 is a clinical study titled "Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries". To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
What is the current status of trial NCT01870401?
This trial is currently completed. It is a NA study. The enrollment target is 442 participants. The study started on 2013-06-03. Estimated completion is 2021-06-22.
What conditions does trial NCT01870401 study?
This clinical trial studies the following conditions: Critical Limb Ischemia.
What interventions are being tested in trial NCT01870401?
The interventions under investigation include: Lutonix DCB (DEVICE), Uncoated PTA Catheter (DEVICE).
Who is sponsoring clinical trial NCT01870401?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01870401 being conducted?
This trial has 20 study locations across Connecticut, District of Columbia, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.