Trial · NCT00823212
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions
NCT00823212, Phase 3, Completed, Boston Scientific Corporation; results first posted 2012-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions. Trials, record NCT00823212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00823212
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions
- NCT number
- NCT00823212
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,530 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Coronary Artery Disease
- Interventions
- PROMUS Coronary Stent System, PROMUS Element Coronary Stent System, Aspirin, Thienopyridine
- First posted
- 2009-01-15
- Last updated
- 2019-03-27
- Results first posted
- 2012-01-27
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Target Lesion Failure (TLF) | 12-month post index procedure | Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
| Secondary | Target Lesion Failure (TLF) | 30 days | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
| Secondary | Target Lesion Failure (TLF) | 6 months | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
| Secondary | Target Lesion Failure (TLF) | 12 months | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
| Secondary | Target Vessel Failure (TVF) | 30 days | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. |
| Secondary | Target Vessel Failure (TVF) | 6 months | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. |
| Secondary | Target Vessel Failure (TVF) | 12 months | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. |
| Secondary | Myocardial Infarction (MI) Related to the Target Vessel | 30 days | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal |
| Secondary | Myocardial Infarction (MI) Related to the Target Vessel | 6 months | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal |
| Secondary | Myocardial Infarction (MI) Related to the Target Vessel | 12 months | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Target Lesion Failure (TLF) | 12-month post index procedure | The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set. | percentage of participants | NUMBER |
| SECONDARY | Target Lesion Failure (TLF) | 30 days | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Percentage of participants | NUMBER |
| SECONDARY | Target Lesion Failure (TLF) | 6 months | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Target Lesion Failure (TLF) | 12 months | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Target Vessel Failure (TVF) | 30 days | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Target Vessel Failure (TVF) | 6 months | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Target Vessel Failure (TVF) | 12 months | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Myocardial Infarction (MI) Related to the Target Vessel | 30 days | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Myocardial Infarction (MI) Related to the Target Vessel | 6 months | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | percentage of participants | NUMBER |
| SECONDARY | Myocardial Infarction (MI) Related to the Target Vessel | 12 months | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | percentage of participants | NUMBER |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Target Lesion Failure (TLF) | PROMUS | 2.9 | percentage of participants | ||
| Target Lesion Failure (TLF) | PROMUS Element | 3.4 | percentage of participants | ||
| Target Lesion Failure (TLF) | PROMUS | 1.4 | Percentage of participants | ||
| Target Lesion Failure (TLF) | PROMUS Element | 0.9 | Percentage of participants | ||
| Target Lesion Failure (TLF) | PROMUS | 1.9 | percentage of participants | ||
| Target Lesion Failure (TLF) | PROMUS Element | 1.7 | percentage of participants | ||
| Target Lesion Failure (TLF) | PROMUS | 3.2 | percentage of participants | ||
| Target Lesion Failure (TLF) | PROMUS Element | 3.5 | percentage of participants | ||
| Target Vessel Failure (TVF) | PROMUS | 1.4 | percentage of participants | ||
| Target Vessel Failure (TVF) | PROMUS Element | 0.9 | percentage of participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PROMUS | 762 | |
| Overall Study | STARTED | PROMUS Element | 768 | |
| Overall Study | COMPLETED | PROMUS | 727 | |
| Overall Study | COMPLETED | PROMUS Element | 735 | |
| Overall Study | NOT COMPLETED | PROMUS | 35 | |
| Overall Study | NOT COMPLETED | PROMUS Element | 33 |
Source ClinicalTrials.gov
Adverse events562
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 | Angina pectoris | Cardiac disorders | PROMUS | 79 | 762 | 86 |
| other | Angina pectoris | Cardiac disorders | PROMUS Element | 65 | 768 | 73 |
| other | Myocardial infarction | Cardiac disorders | PROMUS | 28 | 762 | 28 |
| other | Myocardial infarction | Cardiac disorders | PROMUS Element | 41 | 768 | 41 |
| other | Adverse drug reaction | General disorders | PROMUS | 28 | 762 | 28 |
| other | Adverse drug reaction | General disorders | PROMUS Element | 40 | 768 | 44 |
| other | Catheter site haematoma | General disorders | PROMUS | 41 | 762 | 41 |
| other | Catheter site haematoma | General disorders | PROMUS Element | 41 | 768 | 42 |
| other | Non-cardiac chest pain | General disorders | PROMUS | 53 | 762 | 59 |
| other | Non-cardiac chest pain | General disorders | PROMUS Element | 49 | 768 | 53 |
1 to 10 of 562Source ClinicalTrials.gov
See all 562 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PROMUS | ||
| Total, all-cause mortality | PROMUS Element | ||
| Total, other adverse events | PROMUS | 190 | 762 |
| Total, other adverse events | PROMUS Element | 197 | 768 |
| Total, serious adverse events | PROMUS | 237 | 762 |
| Total, serious adverse events | PROMUS Element | 238 | 768 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PROMUS vs PROMUS Element: serious adverse events |
Source Trial comparisons
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/NCT00823212
GET https://conductscience.org/api/trials/v1/NCT00823212/registered?page=2