TAXUS Liberte`
Eligibility
Persons may be eligible to participate in this trial if they meet the following criteria.
- Patient is >18 years of age
- Consecutive patients who are eligible ro receive a TAXUS Liberte` Stent and the study-required DAPT will be evaluated for the study
- Patients in whom the treating physician has determined that the TAXUS Liberte' Stent is the most appropriate device even if outside of the approved indication
Persons may be excluded from this trial if they meet the following criteria.
- Known hypersensitivity to paclitaxel or structurally related compounds
- known hypersensitivity to the polymer or any of its individual componenents
- Patient judged to have a lesion that pervents 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 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 Liberte' 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 aprior transient ischemic attack (TIA) or a prior stroke
- Patient requiring chronic daily use (greter than 2 consecutive weeks) of a non-steroidal anti-inflammatory drugs (NSAIDS) with the exception of aspirin. Occassional use of NSAIDS on an as needed or "prn" schedule is not exclusionary
- Patine with active pathological bleeding (such as peptic ulcer or intracranial hemorrhage
Complete Title
TAXUS Liberte` Post Approval Study
Purpose
The TAXUS Liberte` 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 Liberte`Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen. This study is designed to evaluate the optimal duration of dual antiplatelet therapy.
Summary
This is a consecutively-enrolled study with patient follow-up through five years post index procedure. This study also will contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate optimal duration of dual antiplatelet therapy (DAPT Study).
Sponsor(s)
- Boston Scientific Corporation