Coronary Artery DiseasePhase 4NCT01589978

PROMUS Element Plus US Post-Approval Study

A Phase 4 study testing PROMUS Element Plus Coronary Stent System, Aspirin and P2Y12 antagonist in people with Coronary Artery Disease, run by Boston Scientific Corporation at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Coronary Artery Disease
What is being tested?: PROMUS Element Plus Coronary Stent System, Aspirin and P2Y12 antagonist
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,681 participants
Where: 52 sitesUnited States
Study dates: May 2012to Jun 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

The population will include consecutive, consented patients.

Who cannot join

There are no exclusion criteria in this all-comers study.

Trial locations and contacts

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

United States52 sites

Piedmont Hospital
Atlanta, Georgia, 30309
South Austin Hospital
Austin, Texas, 78745
Eastern Maine Medical Center
Bangor, Maine, 04401
Brandon Regional Hospital
Brandon, Florida, 33511
IU Health North Medical Center
Carmel, Indiana, 46032
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Mercy Hospital
Coon Rapids, Minnesota, 55433
VA North Texas Health Care System
Dallas, Texas, 75216
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
Doylestown Hospital
Doylestown, Pennsylvania, 18901
North Florida Regional Medical Center
Gainesville, Florida, 32605
University Medical Center-Greenville Memorial Hospital
Greenville, South Carolina, 29605
St. Francis Health System - St. Francis Hospital
Greenville, South Carolina, 29607
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Forest County General Hospital
Hattiesburg, Mississippi, 39401
Memorial Regional Hospital
Hollywood, Florida, 33021
Huntsville Hospital - The Heart Center, PC
Huntsville, Alabama, 35801
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Franciscan St. Francis Hospital
Indianapolis, Indiana, 46237
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46250
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401
St. Joseph Hospital
Lexington, Kentucky, 40504
Loma Linda University Medical Center
Loma Linda, California, 92354
Coliseum Medical Center
Macon, Georgia, 31217
Meriter Hospital
Madison, Wisconsin, 53713
Mount Sinai Medical Center
Miami Beach, Florida, 33140
North Memorial Medical Center
Minneapolis, Minnesota, 55422
Springhill Medical Center
Mobile, Alabama, 36608
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, 29572
New York University Medical Center
New York, New York, 10011
Christiana Hospital
Newark, Delaware, 19718
Orlando Regional Medical Center
Orlando, Florida, 32806
Bay Medical Center
Panama City, Florida, 32401
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Blessing Hospital
Quincy, Illinois, 62301
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Chippenham Medical Center
Richmond, Virginia, 23225
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Redmond Regional Medical Center
Rome, Georgia, 30165
Mercy General Hospital
Sacramento, California, 95819
Lakeland Hospitals at St. Joseph
Saint Joseph, Michigan, 49085
United Hospital - St. Paul Heart Clinic
Saint Paul, Minnesota, 55102
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
Cardiovascular Research, LLC
Shreveport, Louisiana, 71103
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, 57108
St. John's Regional Health Center (Springfield)
Springfield, Missouri, 65804
Cox Medical Centers
Springfield, Missouri, 65807
Martin Memorial Health Systems - Martin Memorial Medical Center
Stuart, Florida, 34996
St. Francis Hospital
Tulsa, Oklahoma, 74136
St. Elizabeth Medical Center
Utica, New York, 13501
Marshfiled Clinic
Weston, Wisconsin, 55476

Other trials in United States

About this study

Official title: A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System

This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.

Read the detailed description

The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length. The proposed study will compile real-world clinical outcomes data for the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.

Patients enrolled in this study are expected to follow antiplatelet therapy recommendations per American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines for percutaneous coronary intervention (PCI). Recommended medications include aspirin, which should be taken for 3 days prior to the procedure or as a peri-procedural loading dose and then continued indefinitely. Additionally, one of the following P2Y12 antagonists may be given in a peri-procedural loading dose and in a maintenance dose per physician discretion: clopidogrel, prasugrel, ticagrelor, or ticlopidine.

Conditions: Coronary Artery Disease
Being tested: PROMUS Element Plus Coronary Stent System, Aspirin, P2Y12 antagonist
Keywords: drug-eluting stent, DES, atherosclerosis, everolimus
Medical subject headings: Coronary Artery Disease, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PROMUS Element Plus Coronary Stent SystemDevice
Also called PROMUS Element stent
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).
AspirinDrug
Also called Acetyl salicylic acid
Aspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.
P2Y12 antagonistDrug
Also called PLAVIX (clopidogrel), TICLID (ticlopidine), EFFIENT (prasugrel), BRILINTA (ticagrelor)
Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI.
- Clopidogrel: Per treating physician, peri-procedural loading dose (300-600 mg), subsequent maintenance dose (75 mg daily)
- Prasugrel: Per treating physician, peri-procedural loading dose (60 mg), subsequent maintenance dose (10 or 5 mg daily per product labeling)
- Ticagrelor: Per treating physician, peri-procedural loading dose (180 mg), subsequent maintenance dose (90 mg 2x daily); maintenance aspirin doses >100 mg may reduce ticagrelor effectiveness and should be avoided.
- Ticlopidine: Per treating physician, if allergy/intolerance to clopidogrel, prasugrel, and/or ticagrelor, loading dose (500 mg), subsequent maintenance dose (250 mg 2x daily)

Study groups in NCT01589978
Study group	Role	What they receive
PROMUS Element	Experimental	Subjects who receive the PROMUS Element everolimus-eluting coronary stent Receives: Device: PROMUS Element Plus Coronary Stent System; Drug: Aspirin; Drug: P2Y12 antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients
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%)
Measured: 12 months

Secondary outcomes (20)

Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients
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%)
Measured: 12 months
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients
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)
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Longitudinal Stent Deformation
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.
Measured: Index Procedure
Major Adverse Cardiac Event Rate (MACE)
Composite of cardiac death, myocardial infarction, and target vessel revascularization
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent
Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Myocardial Infarction (MI) Rate
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
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent
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
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Cardiac Death Rate
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
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Cardiac Death Events Related to the PROMUS Element Stent
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
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Target Vessel Revascularization (TVR) Rate
Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent
Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Cardiac Death or Myocardial Infarction (MI) Rate
See individual descriptions of events.
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent
See individual descriptions of events.
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Target Vessel Failure (TVF) Rate
Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) 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 MI or death was related to the target vessel it will be considered TVF.
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent
Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) 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 MI or death was related to the target vessel it will be considered TVF.
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
All Death Rate
All death includes cardiac death and non-cardiac death.
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Non-cardiac Death Rate
Non-cardiac death is defined as death not due to cardiac causes.
Cardiac death is 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.
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
All Death or Myocardial Infarction Rate
See description of individual events.
Measured: ≤24 hours, 30 days, 180 days, annually through 5 years
Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients
Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)
Measured: 12 Months
ARC ST Rate in PLATINUM-like Population.
Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).
Measured: Annually through 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Jun 2018

First posted2 May 2012 (estimated)
Study startMay 2012
Primary completionAug 2014
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,681 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01589978
Sponsor's protocol ID: S2066
Status last verified: Jun 2018
First submitted: 1 May 2012
Last updated: 26 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Beerkens FJ, Cao D, Batchelor W, Sartori S, Kandzari DE, Davis S, Tamis L, Wang JC, Othman I, Vogel B, Spirito A, Subramaniam V, Gigliotti OS, Haghighat A, Feng Y, Singh S, Lopez M, Giugliano G, Horwitz PA, Dangas G, Mehran R. Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries). Am J Cardiol. 2023 Aug 1;200:204-211. doi: 10.1016/j.amjcard.2023.05.028. Epub 2023 Jun 22.
PubMed 37354778
Batchelor WB, Damluji AA, Yong C, Fiuzat M, Barnett SD, Kandzari DE, Sherwood MW, Epps KC, Tehrani BN, Allocco DJ, Meredith IT, Lindenfeld J, O'Connor CM, Mehran R. Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries. Am Heart J. 2021 Jun;236:37-48. doi: 10.1016/j.ahj.2021.02.003. Epub 2021 Feb 24.
PubMed 33636137
Kandzari DE, Amjadi N, Caputo C, Rowe SK, Williams J, Tamboli HP, Christen T, Allocco DJ, Dawkins KD. One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]). Am J Cardiol. 2016 Feb 15;117(4):539-545. doi: 10.1016/j.amjcard.2015.11.043. Epub 2015 Dec 7.
PubMed 26732420

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
ClinicalTrials.gov ID: NCT01589978
Acronym / sponsor ID: S2066
Conditions: Coronary Artery Disease
Keywords: drug-eluting stent, DES, atherosclerosis, everolimus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,681 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Aug 2014 (actual)
Study completion: Jun 2018 (actual)
First posted: 2 May 2012 (estimated)
Results: Posted 3 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PROMUS Element	Experimental	Device: PROMUS Element Plus Coronary Stent System, Drug: Aspirin, Drug: P2Y12 antagonistSubjects who receive the PROMUS Element everolimus-eluting coronary stent

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

The population will include consecutive, consented patients.

Key exclusion criteria (1 listed)

There are no exclusion criteria in this all-comers study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PROMUS Element Plus Coronary Stent SystemAlso: PROMUS Element stentPROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).	Device	PROMUS Element
AspirinAlso: Acetyl salicylic acidAspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.	Drug	PROMUS Element
P2Y12 antagonistAlso: PLAVIX (clopidogrel), TICLID (ticlopidine), EFFIENT (prasugrel), BRILINTA (ticagrelor)Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI. * Clopidogrel: Per treating physician, peri-procedural loading dose (300-600 mg), subsequent maintenance dose (75 mg daily) * Prasugrel: Per treating physician, peri-procedural loading dose (60 mg), subsequent maintenance dose (10 or 5 mg daily per product labeling) * Ticagrelor: Per treating physician, peri-procedural loading dose (180 mg), subsequent maintenance dose (90 mg 2x daily); maintenance aspirin doses >100 mg may reduce ticagrelor effectiveness and should be avoided. * Ticlopidine: Per treating physician, if allergy/intolerance to clopidogrel, prasugrel, and/or ticagrelor, loading dose (500 mg), subsequent maintenance dose (250 mg 2x daily)	Drug	PROMUS Element

Primary outcome

Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients
Time frame: 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%)

20 secondary outcomes

Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients
Time frame: 12 months
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Longitudinal Stent Deformation
Time frame: Index Procedure
Major Adverse Cardiac Event Rate (MACE)
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Myocardial Infarction (MI) Rate
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Cardiac Death Rate
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Cardiac Death Events Related to the PROMUS Element Stent
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target Vessel Revascularization (TVR) Rate
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Cardiac Death or Myocardial Infarction (MI) Rate
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target Vessel Failure (TVF) Rate
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
All Death Rate
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Non-cardiac Death Rate
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
All Death or Myocardial Infarction Rate
Time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients
Time frame: 12 Months
ARC ST Rate in PLATINUM-like Population.
Time frame: Annually through 5 years

Results and safety

Results posted to the registry on 3 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PROMUS Element Overall Population	2,681	2,681

Primary outcome: Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients

Time frame: 12 months. Number. Unit: percentage of patients

Measure	PROMUS Element n = 1907
Value	1.78

PROMUS Element: p <.0001, Chi-squared

Population analysed: 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.

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).. Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PROMUS Element	780 of 2,681 (29.1%)	5 of 2,681 (0.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37354778Beerkens FJ, Cao D, Batchelor W, Sartori S, Kandzari DE, Davis S, Tamis L, Wang JC, Othman I, Vogel B, Spirito A, Subramaniam V, Gigliotti OS, Haghighat A, Feng Y, Singh S, Lopez M, Giugliano G, Horwitz PA, Dangas G, Mehran R. Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries). Am J Cardiol. 2023 Aug 1;200:204-211. doi: 10.1016/j.amjcard.2023.05.028. Epub 2023 Jun 22.
Derived from this study: PubMed 33636137Batchelor WB, Damluji AA, Yong C, Fiuzat M, Barnett SD, Kandzari DE, Sherwood MW, Epps KC, Tehrani BN, Allocco DJ, Meredith IT, Lindenfeld J, O'Connor CM, Mehran R. Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries. Am Heart J. 2021 Jun;236:37-48. doi: 10.1016/j.ahj.2021.02.003. Epub 2021 Feb 24.
Derived from this study: PubMed 26732420Kandzari DE, Amjadi N, Caputo C, Rowe SK, Williams J, Tamboli HP, Christen T, Allocco DJ, Dawkins KD. One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]). Am J Cardiol. 2016 Feb 15;117(4):539-545. doi: 10.1016/j.amjcard.2015.11.043. Epub 2015 Dec 7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter M Maurer, MPH study director

Boston Scientific Corporation

52 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01589978, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.