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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: Completed NA study of Critical Limb Ischemia, sponsored by C. R. Bard.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary safety endpoint is defined as freedom from the composite of all-cause death, above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery.
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 |
What the finished NCT01870401 record still lists
NCT01870401 is an interventional study that assigns participants to a tested intervention. The registered 442 participants enrollment target is mid-sized for trials with a published cap, above the 67-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (560% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Where NCT01870401's enrollment target sits among peer trials
442 1st of 18 higher than 18 of 18 other Critical Limb Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Limb Ischemia 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.
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