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Completed Phase 4 Interventional Results available

PROMUS Element Plus US Post-Approval Study

ClinicalTrials.gov ID: NCT01589978

Public ClinicalTrials.gov record NCT01589978. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 2:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01589978
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Boston Scientific Corporation
Industry
Enrollment
2,681 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2012 (Type not available)
Primary completion
Aug 2014 (Actual)
Completion
Jun 2018 (Actual)
Last update posted
Jul 26, 2018

2012 – 2018

United States locations

U.S. sites
52
U.S. states
27
U.S. cities
47
Facility City State ZIP Site status
Huntsville Hospital - The Heart Center, PC Huntsville Alabama 35801 —
Springhill Medical Center Mobile Alabama 36608 —
NEA Baptist Memorial Hospital Jonesboro Arkansas 72401 —
St. Bernard's Medical Center Jonesboro Arkansas 72401 —
Loma Linda University Medical Center Loma Linda California 92354 —
Mercy General Hospital Sacramento California 95819 —
Christiana Hospital Newark Delaware 19718 —
Brandon Regional Hospital Brandon Florida 33511 —
North Florida Regional Medical Center Gainesville Florida 32605 —
Memorial Regional Hospital Hollywood Florida 33021 —
Mount Sinai Medical Center Miami Beach Florida 33140 —
Orlando Regional Medical Center Orlando Florida 32806 —
Bay Medical Center Panama City Florida 32401 —
Martin Memorial Health Systems - Martin Memorial Medical Center Stuart Florida 34996 —
Piedmont Hospital Atlanta Georgia 30309 —
Coliseum Medical Center Macon Georgia 31217 —
Redmond Regional Medical Center Rome Georgia 30165 —
Blessing Hospital Quincy Illinois 62301 —
IU Health North Medical Center Carmel Indiana 46032 —
Franciscan St. Francis Hospital Indianapolis Indiana 46237 —
Community Heart and Vascular Hospital Indianapolis Indiana 46250 —
St. Joseph Hospital Lexington Kentucky 40504 —
Cardiovascular Research, LLC Shreveport Louisiana 71103 —
Eastern Maine Medical Center Bangor Maine 04401 —
Cape Cod Hospital Hyannis Massachusetts 02601 —
Lakeland Hospitals at St. Joseph Saint Joseph Michigan 49085 —
Mercy Hospital Coon Rapids Minnesota 55433 —
North Memorial Medical Center Minneapolis Minnesota 55422 —
United Hospital - St. Paul Heart Clinic Saint Paul Minnesota 55102 —
Forest County General Hospital Hattiesburg Mississippi 39401 —
St. John's Regional Health Center (Springfield) Springfield Missouri 65804 —
Cox Medical Centers Springfield Missouri 65807 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
New York University Medical Center New York New York 10011 —
St. Elizabeth Medical Center Utica New York 13501 —
Novant Health Presbyterian Medical Center Charlotte North Carolina 28204 —
St. Francis Hospital Tulsa Oklahoma 74136 —
Doylestown Hospital Doylestown Pennsylvania 18901 —
Presbyterian University of Pennsylvania Medical Center Philadelphia Pennsylvania 19104 —
University Medical Center-Greenville Memorial Hospital Greenville South Carolina 29605 —
St. Francis Health System - St. Francis Hospital Greenville South Carolina 29607 —
Grand Strand Regional Medical Center Myrtle Beach South Carolina 29572 —
Rapid City Regional Hospital Rapid City South Dakota 57701 —
Avera Heart Hospital of South Dakota Sioux Falls South Dakota 57108 —
South Austin Hospital Austin Texas 78745 —
VA North Texas Health Care System Dallas Texas 75216 —
Presbyterian Hospital of Dallas Dallas Texas 75231 —
University of Utah Hospital and Clinics Salt Lake City Utah 84132 —
Chippenham Medical Center Richmond Virginia 23225 —
Carilion Roanoke Memorial Hospital Roanoke Virginia 24014 —
Meriter Hospital Madison Wisconsin 53713 —
Marshfiled Clinic Weston Wisconsin 55476 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01589978, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 26, 2018 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01589978 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →