TAXUS Libertē Post Approval Study

Not Recruiting

Trial ID: NCT00997503


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).

Official Title

TAXUS Libertē Post Approval Study: A U.S. Post-Approval Study of the TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System

Stanford Investigator(s)

Alan Yeung, MD
Alan Yeung, MD

Li Ka Shing Professor in Cardiology

William Fearon, MD
William Fearon, MD

Professor of Medicine (Cardiovascular Medicine)

Jennifer Tremmel
Jennifer Tremmel

Susan P. and Riley P. Bechtel Medical Director and Associate Professor of Medicine (Cardiovascular Medicine)


Enrollment Inclusion Criteria

   - Patient is > 18 years of age.

   - Consecutive patients who have signed an Informed Consent Form, who do not otherwise
   meet applicable exclusion criteria, and who are eligible to receive a TAXUS Liberté
   Stent and the study required DAPT will be evaluated for enrollment in this study.

Enrollment Exclusion Criteria

   - Patient with known hypersensitivity to paclitaxel or structurally related compounds.

   - Patient with known hypersensitivity to the polymer or any of its individual

   - 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

   - Patient who experienced a prior transient ischemic attack (TIA) or a prior stroke.

   - Patient requiring chronic daily use (greater than 2 consecutive weeks) of
   non-steroidal anti-inflammatory drugs (NSAIDs) with the exception of aspirin.
   Occasional use of NSAIDs on an as needed or "prn" schedule is not exclusionary.

   - Patient with active pathological bleeding (such as peptic ulcer or intracranial

Additional Exclusion Criteria (applicable only after patient enrollment has reached
approximately 3600)

   - Patient who experienced a myocardial infarction (MI) within 72 hours prior to the
   index procedure.

   - Patient with a history of (includes current) left main coronary artery disease.

   - Patient who requires stenting of > 1 vessel with a TAXUS Liberté stent during the
   index procedure.

   - Patient who requires stenting of > 2 vessels during the index procedure.

   - Patient who requires a staged procedure within 6-weeks following the index procedure,
   in whom > 1 vessel was stented during the index procedure.

   - Patient with cardiogenic shock.

   - Patient with acute or chronic renal dysfunction (serum creatinine >3.0 mg/dl or
   patient receiving dialysis).

   - Target Lesion that meets any of the following criteria:

      - Located within a saphenous vein graft or an arterial graft

      - Chronic total occlusion

      - Restenosis from a previously implanted drug-eluting or bare-metal stent

      - Previous use of intravascular brachytherapy in target vessel

      - Lesion involves a bifurcation

      - Lesion is ostial in location

      - Severe tortuosity in the target lesion or target vessel proximal to the target

      - Moderate or severe calcification by visual estimate in the target lesion or
      target vessel proximal to the target lesion

      - RVD < 2.5 mm or RVD > 3.75 mm

      - Lesion length > 28 mm

Randomization Inclusion Criteria (12-months):

   - Patient is "12-Month Clear," which is defined as patients enrolled in the study who
   are free from all death, MI, stroke, repeat coronary revascularization, stent
   thrombosis and major bleeding (severe or moderate by GUSTO classification) 12 months
   after stent implantation and who are compliant with 12 months of DAPT following stent
   implantation. Exceptions to this rule are: Patients who experience repeat PCI, stent
   thrombosis and/or myocardial infarction occurring within 6 weeks after the index
   procedure will not be excluded from the definition of 12-Month Clear.

   - Patient was compliant with DAPT during the first 12 months of the study. Compliance is
   defined as the patient taking between 80% and 120% of prasugrel in the 0-6 month and
   6-12 month periods without an interruption of therapy longer than 14 days. Compliance
   at both time points is required to be considered 12-Month Clear.

Randomization Exclusion Criteria (12-months):

   - Known pregnancy.

   - Patient switched from prasugrel to other thienopyridine after discharge from index

   - Patient switched maintenance dose of prasugrel (such as 10mg to 5mg; or 5mg to 10mg)
   within 6-months prior to randomization.

   - Percutaneous coronary intervention or cardiac surgery between 6 weeks post index
   procedure and randomization.

   - Planned surgery necessitating discontinuation of antiplatelet therapy (> 14 days)
   within the 21 months following randomization.

   - Patients on warfarin or similar anticoagulant therapy.

   - Current medical condition with life expectancy of less than 3 years.


device: TAXUS Liberté Paclitaxel-Eluting Coronary Stent

drug: prasugrel

drug: placebo

drug: aspirin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Yvonne Strawa