LEADERS FREE II: BioFreedom™ Pivotal Study
Public ClinicalTrials.gov record NCT02843633. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02843633
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,203 participants
Conditions and interventions
Conditions
Interventions
Device · Drug
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2017 (Actual)
- Primary completion
- Oct 11, 2018 (Actual)
- Completion
- Mar 2021 (Estimated)
- Last update posted
- Feb 3, 2021
2017 – 2021
United States locations
- U.S. sites
- 39
- U.S. states
- 23
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | — |
| Tri-Lakes Research | Hot Springs | Arkansas | 71901 | — |
| Scripps Health | La Jolla | California | 92037 | — |
| University of California San Diego | La Jolla | California | 92037 | — |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93102 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida Jacksonville | Jacksonville | Florida | 32209 | — |
| Velella Research | Sarasota | Florida | 34239 | — |
| Tallahassee Research Institute, Inc. | Tallahassee | Florida | 32308 | — |
| North Georgia Heart Foundation | Gainesville | Georgia | 30501 | — |
| St. Luke's Idaho Cardiology Associates | Boise | Idaho | 83712 | — |
| Jesse Brown VA Medical Center | Chicago | Illinois | 60612 | — |
| St. Vincent Heart Center | Indianapolis | Indiana | 46290 | — |
| Jewish and St. Mary's Hospital | Louisville | Kentucky | 40202 | — |
| Lahey Clinic | Burlington | Massachusetts | 01805 | — |
| McLaren Bay Region | Bay City | Michigan | 48708 | — |
| MidMichigan Medical Center Midland | Midland | Michigan | 48670 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Missouri Cardiovascular Specialists, LLP | Columbia | Missouri | 65201 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| University of Buffalo | Buffalo | New York | 14203 | — |
| Weill Cornell Medical College-New York Presbyterian | New York | New York | 10021 | — |
| Columbia University Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | — |
| Novant Health Heart and Vascular Institute | Charlotte | North Carolina | 28204 | — |
| LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | — |
| NC Heart and Vascular Research | Raleigh | North Carolina | 27607 | — |
| Genesis Healthcare System | Zanesville | Ohio | 43701 | — |
| Penn State - Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Berks Cardiologists, Ltd. | Reading | Pennsylvania | 19610 | — |
| Pinnacle Health Cardiovascular Institute | Wormleysburg | Pennsylvania | 17043 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| AnMed Health | Anderson | South Carolina | 29621 | — |
| Black Hills Cardiovascular Research | Rapid City | South Dakota | 57701 | — |
| Chattanooga Heart Institute | Chattanooga | Tennessee | 37404 | — |
| Tennova Healthcare-Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Providence Health Center | Waco | Texas | 76712 | — |
| Carilion Clinic | Roanoke | Virginia | 24014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02843633, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 3, 2021 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02843633 live on ClinicalTrials.gov.