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NCT02843633 · ClinicalTrials.gov registry record · NA
LEADERS FREE II: BioFreedom™ Pivotal Study
A NA study of Acute Coronary Syndrome and High Bleeding Risk, sponsored by Biosensors Europe.
- Active
- Registry status
- NA
- Development phase
- 1,203
- Enrollment target
- 20
- Study locations
NCT02843633 is a NA study of Acute Coronary Syndrome and High Bleeding Risk that is active but no longer recruiting, run by Biosensors Europe. The registered enrollment target is 1,203 participants, below the 2,692-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT02843633, a NA study of Acute Coronary Syndrome and High Bleeding Risk, is active but no longer recruiting, sponsored by Biosensors Europe.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,203 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
Conditions Studied
Interventions
- DEVICE BioFreedom™ Drug Coated Coronary Stent System
- DRUG Antiplatelet Drug
Study Locations (20)
California
- Scripps Health - La Jolla
- University of California San Diego - La Jolla
- Santa Barbara Cottage Hospital - Santa Barbara
Florida
- University of Florida Jacksonville - Jacksonville
- Velella Research - Sarasota
- Tallahassee Research Institute, Inc. - Tallahassee
Michigan
- McLaren Bay Region - Bay City
- MidMichigan Medical Center Midland - Midland
- William Beaumont Hospital - Royal Oak
Missouri
- Missouri Cardiovascular Specialists, LLP - Columbia
- Saint Luke's Hospital of Kansas City - Kansas City
Alabama
- Heart Center Research, LLC - Huntsville
Arkansas
- Tri-Lakes Research - Hot Springs
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Georgia
- North Georgia Heart Foundation - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,203 participants |
| Start Date | 2017-02-14 |
| Est. Completion | 2021-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02843633
The ClinicalTrials.gov registry entry for NCT02843633 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 1,203 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,692-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (55% lower). The listed sponsor is Biosensors Europe, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Coronary Syndrome appearing as the primary indexed condition, and to 2 interventions - of which BioFreedom™ Drug Coated Coronary Stent System is the first listed.
NCT02843633 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT02843633 about?
NCT02843633 is a clinical study titled "LEADERS FREE II: BioFreedom™ Pivotal Study". This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
What is the current status of trial NCT02843633?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,203 participants. The study started on 2017-02-14. Estimated completion is 2021-03.
What conditions does trial NCT02843633 study?
This clinical trial studies the following conditions: Acute Coronary Syndrome, High Bleeding Risk.
What interventions are being tested in trial NCT02843633?
The interventions under investigation include: BioFreedom™ Drug Coated Coronary Stent System (DEVICE), Antiplatelet Drug (DRUG).
Who is sponsoring clinical trial NCT02843633?
This trial is sponsored by Biosensors Europe, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02843633 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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