Trial · NCT01589978
PROMUS Element Plus US Post-Approval Study
NCT01589978, Phase 4, Completed, Boston Scientific Corporation; results first posted 2016-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PROMUS Element Plus US Post-Approval Study. Trials, record NCT01589978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01589978
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PROMUS Element Plus US Post-Approval Study
- NCT number
- NCT01589978
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,681 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Coronary Artery Disease
- Interventions
- PROMUS Element Plus Coronary Stent System, Aspirin, P2Y12 antagonist
- First posted
- 2012-05-02
- Last updated
- 2018-07-26
- Results first posted
- 2016-05-03
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients | 12 months | Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and \<2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%) |
| Secondary | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients | 12 months | ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and \<2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%) |
| Secondary | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients | ≤24 hours, 30 days, 180 days, annually through 5 years | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) |
| Secondary | Rate of Longitudinal Stent Deformation | Index Procedure | Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent. |
| Secondary | Major Adverse Cardiac Event Rate (MACE) | ≤24 hours, 30 days, 180 days, annually through 5 years | Composite of cardiac death, myocardial infarction, and target vessel revascularization |
| Secondary | Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent | ≤24 hours, 30 days, 180 days, annually through 5 years | Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent |
| Secondary | Myocardial Infarction (MI) Rate | ≤24 hours, 30 days, 180 days, annually through 5 years | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin \>upper limit of normal(ULN); if no new Q-waves total CK levels \>3×ULN (peri-percutaneous coronary intervention \[PCI\]) or \>2×ULN (spontaneous) with elevated CK-MB or troponin \>3×ULN (peri-PCI) or \>2×ULN (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 for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5×ULN |
| Secondary | Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent | ≤24 hours, 30 days, 180 days, annually through 5 years | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin \>upper limit of normal(ULN); if no new Q-waves total CK levels \>3×ULN (peri-percutaneous coronary intervention \[PCI\]) or \>2×ULN (spontaneous) with elevated CK-MB or troponin \>3×ULN (peri-PCI) or \>2×ULN (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 for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5×ULN |
| Secondary | Cardiac Death Rate | ≤24 hours, 30 days, 180 days, annually through 5 years | Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded |
| Secondary | Rate of Cardiac Death Events Related to the PROMUS Element Stent | ≤24 hours, 30 days, 180 days, annually through 5 years | Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
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 Rate in PLATINUM-like Patients | 12 months | Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module. | percentage of patients | NUMBER |
| SECONDARY | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients | 12 months | PROMUS Element PLATINUM-Like patients (a subgroup of the overall population as described in the Participant Flow Module), N=776. | percentage of patients | NUMBER |
| SECONDARY | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients | ≤24 hours, 30 days, 180 days, annually through 5 years | percentage of patients | NUMBER | |
| SECONDARY | Rate of Longitudinal Stent Deformation | Index Procedure | stents | NUMBER | |
| SECONDARY | Major Adverse Cardiac Event Rate (MACE) | ≤24 hours, 30 days, 180 days, annually through 5 years | percentage of patients | NUMBER | |
| SECONDARY | Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent | ≤24 hours, 30 days, 180 days, annually through 5 years | percentage of patients | NUMBER | |
| SECONDARY | Myocardial Infarction (MI) Rate | ≤24 hours, 30 days, 180 days, annually through 5 years | percentage of patients | NUMBER | |
| SECONDARY | Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent | ≤24 hours, 30 days, 180 days, annually through 5 years | percentage of patients | NUMBER | |
| SECONDARY | Cardiac Death Rate | ≤24 hours, 30 days, 180 days, annually through 5 years | percentage of patients | NUMBER | |
| SECONDARY | Rate of Cardiac Death Events Related to the PROMUS Element Stent | ≤24 hours, 30 days, 180 days, annually through 5 years | percentage of patients | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group21
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 Rate in PLATINUM-like Patients | PROMUS Element | 1.78 | percentage of patients | ||
| Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients | PROMUS Element | 0.3 | percentage of patients | ||
| Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients | PROMUS Element | 0.7 | percentage of patients | ||
| Rate of Longitudinal Stent Deformation | PROMUS Element | 2 | stents | ||
| Major Adverse Cardiac Event Rate (MACE) | PROMUS Element | 6.9 | percentage of patients | ||
| Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent | PROMUS Element | 4.7 | percentage of patients | ||
| Myocardial Infarction (MI) Rate | PROMUS Element | 1.1 | percentage of patients | ||
| Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent | PROMUS Element | 0.7 | percentage of patients | ||
| Cardiac Death Rate | PROMUS Element | 1.4 | percentage of patients | ||
| Rate of Cardiac Death Events Related to the PROMUS Element Stent | PROMUS Element | 1.3 | percentage of patients |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PROMUS Element Overall Population | 2,681 | |
| Overall Study | COMPLETED | PROMUS Element Overall Population | 2,681 | |
| Overall Study | NOT COMPLETED | PROMUS Element Overall Population | 0 |
Source ClinicalTrials.gov
Adverse events345
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 | PROMUS Element | 5 | 2,681 | |
| serious | ANGINA PECTORIS | Cardiac disorders | PROMUS Element | 120 | 2,681 | |
| serious | ANGINA UNSTABLE | Cardiac disorders | PROMUS Element | 93 | 2,681 | |
| serious | CORONARY ARTERY DISEASE | Cardiac disorders | PROMUS Element | 49 | 2,681 | |
| serious | CARDIAC FAILURE CONGESTIVE | Cardiac disorders | PROMUS Element | 46 | 2,681 | |
| serious | ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | PROMUS Element | 33 | 2,681 | |
| serious | MYOCARDIAL INFARCTION | Cardiac disorders | PROMUS Element | 22 | 2,681 | |
| serious | ATRIAL FIBRILLATION | Cardiac disorders | PROMUS Element | 23 | 2,681 | |
| serious | CORONARY ARTERY DISSECTION | Cardiac disorders | PROMUS Element | 19 | 2,681 | |
| serious | CORONARY ARTERY THROMBOSIS | Cardiac disorders | PROMUS Element | 15 | 2,681 |
1 to 10 of 345Source ClinicalTrials.gov
See all 345 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PROMUS Element | ||
| Total, other adverse events | PROMUS Element | 5 | 2,681 |
| Total, serious adverse events | PROMUS Element | 780 | 2,681 |
Source ClinicalTrials.gov
Papers3
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01589978
GET https://conductscience.org/api/trials/v1/NCT01589978/registered?page=2