TAXUS Libertē Post Approval Study
2 other identifiers
observational
4,199
1 country
82
Brief Summary
The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen. This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2009
Longer than P75 for all trials
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2009
CompletedFirst Posted
Study publicly available on registry
October 19, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedResults Posted
Study results publicly available
April 13, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 7, 2015
March 1, 2015
3.2 years
October 15, 2009
March 13, 2014
July 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiac Death or Myocardial Infarction
Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.
12 months
Secondary Outcomes (36)
Incremental Rate of Stent Thrombosis (Protocol Definition)
1-2 years
Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population
12 months
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
6 months
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
12 months
Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related
6 months
- +31 more secondary outcomes
Interventions
The TAXUS Liberté Paclitaxel-Eluting Coronary Stent System is a device/drug combination product comprised of two regulated components: a device (Liberté Coronary Stent System) and a drug product (a formulation of paclitaxel contained in a polymer coating).The polymer coating serves as a carrier system to provide uniform and controlled biphasic release of the drug into the vessel wall once the stent is deployed.
10mg or 5mg, oral, once daily as maintenance dose through 30-months following index procedure
Oral placebo to match both 10mg and 5mg prasugrel tablets.
Oral, as prescribed by physician through end of study. .
Eligibility Criteria
All-comers study with follow-up through 3 years.
You may qualify if:
- Patient is \> 18 years of age.
You may not qualify if:
- Patient with known hypersensitivity to paclitaxel or structurally related compounds.
- Patient with known hypersensitivity to the polymer or any of its individual components.
- Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
- Patient who cannot receive the protocol required dual antiplatelet therapy.
- Patient on warfarin or similar anticoagulant therapy.
- Patient with known pregnancy.
- Planned surgery necessitating discontinuation of antiplatelet therapy(\> 14 days)within the 30-months following enrollment.
- Current medical condition with a life expectancy of less than 3 years.
- Patient currently enrolled in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a drug-eluting stent other than the TAXUS Liberté Stent.
- Patient judged unable to cooperate with prolonged DAPT.
- Patient unable to give informed consent.
- Patient judged inappropriate for randomization due to other condition requiring chronic thienopyridine use.
- Patient treated with both a drug-eluting stent and a bare-metal stent during the index procedure.
- Patient who experienced a prior transient ischemic attack (TIA) or a prior stroke.
- Patient with active pathological bleeding (such as peptic ulcer or intracranial hemorrhage).
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- Eli Lilly and Companycollaborator
- Daiichi Sankyocollaborator
Study Sites (82)
Advanced Cardiac Specialists
Mesa, Arizona, 85206, United States
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401, United States
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401, United States
Baptist Health Medical Center
Little Rock, Arkansas, 72205, United States
Bakersfield Memorial Hospital
Bakersfield, California, 93301, United States
Bakersfield Heart
Bakersfield, California, 93308, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Alvarado Hospital
San Diego, California, 92120, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
St. Anthony Central Hospital
Denver, Colorado, 80204, United States
Medical Center of the Rockies (Loveland)
Loveland, Colorado, 80538, United States
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606, United States
Christiana Hospital
Newark, Delaware, 19718, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
Baptist Medical Center
Jacksonville, Florida, 32207, United States
Memorial Hospital Jacksonville/ Orange Park Medical Center
Jacksonville, Florida, 32216, United States
Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
Florida Hospital
Orlando, Florida, 32803, United States
Baptist Hospital
Pensacola, Florida, 32501, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Bayfront Medical Center
St. Petersburg, Florida, 33705, United States
Martin Memorial Medical Center
Stuart, Florida, 34995, United States
University Community Hospital
Tampa, Florida, 33613, United States
Kaiser Foundation Hospitals
Honolulu, Hawaii, 96819, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814, United States
MacNeal Hospital
Berwyn, Illinois, 60402, United States
Jesse Brown VA Medical Center
Chicago, Illinois, 60612, United States
IU Health North Medical Center
Carmel, Indiana, 46032, United States
Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
King's Daughters Medical Center- Kentucky Heart Institute
Ashland, Kentucky, 41101, United States
St. Joseph Hospital
Lexington, Kentucky, 40504, United States
Christus St. Frances Cabrini Hospital
Alexandria, Louisiana, 71301, United States
Cardiovascular Research, LLC
Shreveport, Louisiana, 71105, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Ingham Regional Medical Center
Lansing, Michigan, 48910, United States
Mid Michigan Medical Center
Midland, Michigan, 48670, United States
St. Mary's Medical Center
Mount Pleasant, Michigan, 48858, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Covenant Medical Center
Saginaw, Michigan, 48602, United States
Lakeland Hospital at St. Joseph
Saint Joseph, Michigan, 49085, United States
Providence Hospital
Southfield, Michigan, 48075, United States
North Memorial Medical Center
Minneapolis, Minnesota, 55422, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39501, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Freeman West Hospital
Joplin, Missouri, 64804, United States
Cox Medical Centers
Springfield, Missouri, 65807, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Our Lady of Lourdes Medical Center
Camden, New Jersey, 08035, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Heart Hospital of New Mexico
Albuquerque, New Mexico, 87102, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Columbia University/ New York Presbyterian Hospital
New York, New York, 10032, United States
St. Elizabeth Medical Center
Utica, New York, 13501, United States
Gaston Memorial Hospital
Gastonia, North Carolina, 28054, United States
Wake Medical Center
Raleigh, North Carolina, 27610, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Med Central Health System- Mid Ohio Heart Clinic
Mansfield, Ohio, 44906, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Conemaugh Valley Memorial Hospital
Johnstown, Pennsylvania, 15905, United States
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Palmetto Richland Memorial Hospital
Columbia, South Carolina, 29203, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, 29204, United States
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, 29572, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, 57108, United States
Jackson Madison County General Hospital
Jackson, Tennessee, 38305, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Doctors Hospital at Renaissance/ McAllen Heart Hospital
Edinburg, Texas, 78539, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
Kingwood Medical Center
Kingwood, Texas, 77339, United States
Methodist Texsan Hospital
San Antonio, Texas, 78201, United States
Cardiovascular Associates of East Texas Medical Center
Tyler, Texas, 75701, United States
Meriter Hospital, Inc.
Madison, Wisconsin, 53715, United States
Related Publications (4)
Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G, Deligonul U, Topol EJ, Bulle TM. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel Angioplasty Prognosis Study Group. Circulation. 1990 Oct;82(4):1193-202. doi: 10.1161/01.cir.82.4.1193.
PMID: 2401060BACKGROUNDLee DP, Paulus R, Giri K, Carr J, Baran KW, Hassel D, Winters KJ, Christen T, Dawkins KD, Garratt KN. TCT-167 Primary endpoint results of the TAXUS Libertē post-approval study. Journal of the American College of Cardiology. 2013;62:B54-B54
RESULTGarratt, KN, Lambert C, Kabour A, Stewart M, Hall P, Phillips WJ, Winters KJ, Christen T, Dawkins KD, Lee DP TCT-148 TAXUS Liberté PES With ASA + Prasugrel Is Associated With Low TVF, Bleeding And Adverse Event Rates Among Diabetic Patients With "On-Label" Stent Indications. Journal of the American College of Cardiology, 2013; 62 (18_S1): B47-B47.
RESULTGarratt KN, Weaver WD, Jenkins RG, Pow TK, Mauri L, Kereiakes DJ, Winters KJ, Christen T, Allocco DJ, Lee DP. Prasugrel plus aspirin beyond 12 months is associated with improved outcomes after TAXUS Liberte paclitaxel-eluting coronary stent placement. Circulation. 2015 Jan 6;131(1):62-73. doi: 10.1161/CIRCULATIONAHA.114.013570. Epub 2014 Nov 16.
PMID: 25400062DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Maurer, Director of Clinical Trials
- Organization
- Boston Scientific Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
David P Lee, MD
Stanford University
- PRINCIPAL INVESTIGATOR
Kirk N Garratt, MD
Lenox Hill Hospital
- STUDY DIRECTOR
Peter M Maurer, MPH
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2009
First Posted
October 19, 2009
Study Start
December 1, 2009
Primary Completion
March 1, 2013
Study Completion
July 1, 2015
Last Updated
August 7, 2015
Results First Posted
April 13, 2015
Record last verified: 2015-03