Trial · NCT00997503
TAXUS Libertē Post Approval Study
NCT00997503, Completed, Boston Scientific Corporation; results first posted 2015-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TAXUS Libertē Post Approval Study. Trials, record NCT00997503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00997503
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TAXUS Libertē Post Approval Study
- NCT number
- NCT00997503
- Status
- Completed
- Enrollment
- 4,199 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Coronary Artery Disease
- Interventions
- TAXUS Liberté Paclitaxel-Eluting Coronary Stent, prasugrel, placebo, aspirin
- First posted
- 2009-10-19
- Last updated
- 2015-08-07
- Results first posted
- 2015-04-13
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cardiac Death or Myocardial Infarction | 12 months | 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. |
| Secondary | Incremental Rate of Stent Thrombosis (Protocol Definition) | 1-2 years | Stent Thrombosis (protocol definition): The occurrence of any of the following: 1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis: Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion 2. Acute MI in the distribution of the treated vessel. 3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available. |
| Secondary | Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population | 12 months | Target vessel failure (TVF) for TAXUS Libertē Post-Approval Study medically-treated diabetic population. For pooled data from the TAXUS Liberté population, please see the citations |
| Secondary | Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 6 months | * MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. * Binary rate |
| Secondary | Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 12 months | * MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. * Binary rate |
| Secondary | Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related | 6 months | MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. |
| Secondary | Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related | 12 months | * MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. * Binary rate |
| Secondary | Rate of Major Adverse Cardiac Events (MACE) | 6 months | * MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate |
| Secondary | Rate of Major Adverse Cardiac Events (MACE) | 12 months | * MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate |
| Secondary | Rate of Major Adverse Cardiac Events (MACE): Study Stent Related | 6 months | * MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cardiac Death or Myocardial Infarction | 12 months | There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. | percentage of participants | NUMBER |
| SECONDARY | Incremental Rate of Stent Thrombosis (Protocol Definition) | 1-2 years | To be analyzed in this secondary analysis, a subject needed to have an endpoint event between 1-2 years or sufficient follow-up through 2-years. There were 448 subjects that did not meet the criteria for this analysis. | percentage of participants | NUMBER |
| SECONDARY | Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population | 12 months | To be included, subject was a medically treated diabetic at the time of enrollment. Also, subjects met the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. There were 2945 subjects that did not meet the criteria for this analysis. | percentage of participants | NUMBER |
| SECONDARY | Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 6 months | There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. | percentage of participants | NUMBER |
| SECONDARY | Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 12 months | There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. | percentage of participants | NUMBER |
| SECONDARY | Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related | 6 months | There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. | percentage of participants | NUMBER |
| SECONDARY | Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related | 12 months | There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. | percentage of participants | NUMBER |
| SECONDARY | Rate of Major Adverse Cardiac Events (MACE) | 6 months | There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. | percentage of participants | NUMBER |
| SECONDARY | Rate of Major Adverse Cardiac Events (MACE) | 12 months | There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. | percentage of participants | NUMBER |
| SECONDARY | Rate of Major Adverse Cardiac Events (MACE): Study Stent Related | 6 months | There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. | percentage of participants | NUMBER |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cardiac Death or Myocardial Infarction | TAXUS Libertē Post-Approval Study Enrolled Population | 2.1 | percentage of participants | ||
| Incremental Rate of Stent Thrombosis (Protocol Definition) | TAXUS Libertē: Overall Enrolled Population | 1.3 | percentage of participants | ||
| Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population | Medically Treated Diabetic Population | 6.1 | percentage of participants | ||
| Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | TAXUS Liberté: Overall Enrolled Population | 4.7 | percentage of participants | ||
| Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | TAXUS Liberté: Overall Enrolled Population | 7.8 | percentage of participants | ||
| Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related | TAXUS Liberté: Overall Enrolled Population | 3.1 | percentage of participants | ||
| Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related | TAXUS Liberté: Overall Enrolled Population | 4.9 | percentage of participants | ||
| Rate of Major Adverse Cardiac Events (MACE) | TAXUS Liberté: Overall Enrolled Population | 4.3 | percentage of participants | ||
| Rate of Major Adverse Cardiac Events (MACE) | TAXUS Liberté: Overall Enrolled Population | 7.3 | percentage of participants | ||
| Rate of Major Adverse Cardiac Events (MACE): Study Stent Related | TAXUS Liberté: Overall Enrolled Population | 3.1 | percentage of participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAXUS Libertē: Overall Enrolled Population | 4,199 | |
| Overall Study | 12 Months | TAXUS Libertē: Overall Enrolled Population | 4,059 | |
| Overall Study | COMPLETED | TAXUS Libertē: Overall Enrolled Population | 3,926 | |
| Overall Study | NOT COMPLETED | TAXUS Libertē: Overall Enrolled Population | 273 |
Source ClinicalTrials.gov
Adverse events510
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Myocardial infarction | Cardiac disorders | TAXUS Liberté: Overall Enrolled Population | 43 | 4,199 | 43 |
| other | Coronary artery disease | Cardiac disorders | TAXUS Liberté: Overall Enrolled Population | 21 | 4,199 | 21 |
| other | Coronary artery dissection | Cardiac disorders | TAXUS Liberté: Overall Enrolled Population | 7 | 4,199 | 7 |
| other | Acute myocardial infarction | Cardiac disorders | TAXUS Liberté: Overall Enrolled Population | 2 | 4,199 | 2 |
| other | Angina pectoris | Cardiac disorders | TAXUS Liberté: Overall Enrolled Population | 1 | 4,199 | 1 |
| other | Angina unstable | Cardiac disorders | TAXUS Liberté: Overall Enrolled Population | 1 | 4,199 | 1 |
| other | Coronary artery stenosis | Cardiac disorders | TAXUS Liberté: Overall Enrolled Population | 1 | 4,199 | 1 |
| other | Coronary artery thrombosis | Cardiac disorders | TAXUS Liberté: Overall Enrolled Population | 1 | 4,199 | 1 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | TAXUS Liberté: Overall Enrolled Population | 47 | 4,199 | 47 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | TAXUS Liberté: Overall Enrolled Population | 1 | 4,199 | 1 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAXUS Liberté: Overall Enrolled Population | ||
| Total, other adverse events | TAXUS Liberté: Overall Enrolled Population | 293 | 4,199 |
| Total, serious adverse events | TAXUS Liberté: Overall Enrolled Population | 1,232 | 4,199 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00997503
GET https://conductscience.org/api/trials/v1/NCT00997503/registered?page=2