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PROMUS Element Plus US Post-Approval Study

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PROMUS Element Plus Coronary Stent System
Aspirin
P2Y12 antagonist
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring drug-eluting stent, DES, atherosclerosis, everolimus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The population will include consecutive, consented patients.

Exclusion Criteria:

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

Sites / Locations

  • Huntsville Hospital - The Heart Center, PC
  • Springhill Medical Center
  • NEA Baptist Memorial Hospital
  • St. Bernard's Medical Center
  • Loma Linda University Medical Center
  • Mercy General Hospital
  • Christiana Hospital
  • Brandon Regional Hospital
  • North Florida Regional Medical Center
  • Memorial Regional Hospital
  • Mount Sinai Medical Center
  • Orlando Regional Medical Center
  • Bay Medical Center
  • Martin Memorial Health Systems - Martin Memorial Medical Center
  • Piedmont Hospital
  • Coliseum Medical Center
  • Redmond Regional Medical Center
  • Blessing Hospital
  • IU Health North Medical Center
  • Franciscan St. Francis Hospital
  • Community Heart and Vascular Hospital
  • St. Joseph Hospital
  • Cardiovascular Research, LLC
  • Eastern Maine Medical Center
  • Cape Cod Hospital
  • Lakeland Hospitals at St. Joseph
  • Mercy Hospital
  • North Memorial Medical Center
  • United Hospital - St. Paul Heart Clinic
  • Forest County General Hospital
  • St. John's Regional Health Center (Springfield)
  • Cox Medical Centers
  • Hackensack University Medical Center
  • New York University Medical Center
  • St. Elizabeth Medical Center
  • Novant Health Presbyterian Medical Center
  • St. Francis Hospital
  • Doylestown Hospital
  • Presbyterian University of Pennsylvania Medical Center
  • University Medical Center-Greenville Memorial Hospital
  • St. Francis Health System - St. Francis Hospital
  • Grand Strand Regional Medical Center
  • Rapid City Regional Hospital
  • Avera Heart Hospital of South Dakota
  • South Austin Hospital
  • VA North Texas Health Care System
  • Presbyterian Hospital of Dallas
  • University of Utah Hospital and Clinics
  • Chippenham Medical Center
  • Carilion Roanoke Memorial Hospital
  • Meriter Hospital
  • Marshfiled Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PROMUS Element

Arm Description

Subjects who receive the PROMUS Element everolimus-eluting coronary stent

Outcomes

Primary Outcome Measures

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%)

Secondary Outcome Measures

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%)
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)
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.
Major Adverse Cardiac Event Rate (MACE)
Composite of cardiac death, myocardial infarction, and target vessel revascularization
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
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
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
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
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
Target Vessel Revascularization (TVR) Rate
Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
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.
Cardiac Death or Myocardial Infarction (MI) Rate
See individual descriptions of events.
Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent
See individual descriptions of events.
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.
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.
All Death Rate
All death includes cardiac death and non-cardiac death.
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.
All Death or Myocardial Infarction Rate
See description of individual events.
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%)
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%).

Full Information

First Posted
May 1, 2012
Last Updated
June 27, 2018
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01589978
Brief Title
PROMUS Element Plus US Post-Approval Study
Official Title
A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
drug-eluting stent, DES, atherosclerosis, everolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2681 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PROMUS Element
Arm Type
Experimental
Arm Description
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Intervention Type
Device
Intervention Name(s)
PROMUS Element Plus Coronary Stent System
Other Intervention Name(s)
PROMUS Element stent
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Acetyl salicylic acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
P2Y12 antagonist
Other Intervention Name(s)
PLAVIX (clopidogrel), TICLID (ticlopidine), EFFIENT (prasugrel), BRILINTA (ticagrelor)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients
Description
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%)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients
Description
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%)
Time Frame
12 months
Title
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients
Description
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)
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Rate of Longitudinal Stent Deformation
Description
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.
Time Frame
Index Procedure
Title
Major Adverse Cardiac Event Rate (MACE)
Description
Composite of cardiac death, myocardial infarction, and target vessel revascularization
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent
Description
Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Myocardial Infarction (MI) Rate
Description
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
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent
Description
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
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Cardiac Death Rate
Description
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
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Rate of Cardiac Death Events Related to the PROMUS Element Stent
Description
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
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Target Vessel Revascularization (TVR) Rate
Description
Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent
Description
Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Cardiac Death or Myocardial Infarction (MI) Rate
Description
See individual descriptions of events.
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent
Description
See individual descriptions of events.
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Target Vessel Failure (TVF) Rate
Description
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.
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent
Description
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.
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
All Death Rate
Description
All death includes cardiac death and non-cardiac death.
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Non-cardiac Death Rate
Description
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.
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
All Death or Myocardial Infarction Rate
Description
See description of individual events.
Time Frame
≤24 hours, 30 days, 180 days, annually through 5 years
Title
Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients
Description
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%)
Time Frame
12 Months
Title
ARC ST Rate in PLATINUM-like Population.
Description
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%).
Time Frame
Annually through 5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The population will include consecutive, consented patients. Exclusion Criteria: There are no exclusion criteria in this all-comers study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Maurer, MPH
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Huntsville Hospital - The Heart Center, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Springhill Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
NEA Baptist Memorial Hospital
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
St. Bernard's Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Brandon Regional Hospital
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
North Florida Regional Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Bay Medical Center
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Martin Memorial Health Systems - Martin Memorial Medical Center
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Coliseum Medical Center
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Redmond Regional Medical Center
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Blessing Hospital
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
IU Health North Medical Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Franciscan St. Francis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Community Heart and Vascular Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
St. Joseph Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Cardiovascular Research, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Cape Cod Hospital
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Lakeland Hospitals at St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
North Memorial Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
United Hospital - St. Paul Heart Clinic
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Forest County General Hospital
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
St. John's Regional Health Center (Springfield)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Cox Medical Centers
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
St. Elizabeth Medical Center
City
Utica
State/Province
New York
ZIP/Postal Code
13501
Country
United States
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Presbyterian University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University Medical Center-Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
St. Francis Health System - St. Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Grand Strand Regional Medical Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Avera Heart Hospital of South Dakota
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
South Austin Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
VA North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Utah Hospital and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Chippenham Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Meriter Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53713
Country
United States
Facility Name
Marshfiled Clinic
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
55476
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33636137
Citation
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.
Results Reference
derived
PubMed Identifier
26732420
Citation
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.
Results Reference
derived

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PROMUS Element Plus US Post-Approval Study

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