PROMUS Element Plus US Post-Approval Study

Completed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01589978

Run by

Boston Scientific Corporation

People needed

2681

Starts

2012-05-01

Expected to finish

2018-06-01

Last updated by the study team

2018-07-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The population will include consecutive, consented patients.

You may not qualify if…

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

Where it is running

• Springhill Medical Center — Mobile, Alabama, United States
• NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States
• St. Bernard's Medical Center — Jonesboro, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Mercy General Hospital — Sacramento, California, United States
• Christiana Hospital — Newark, Delaware, United States
• Brandon Regional Hospital — Brandon, Florida, United States
• North Florida Regional Medical Center — Gainesville, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Orlando Regional Medical Center — Orlando, Florida, United States
• Bay Medical Center — Panama City, Florida, United States
• Martin Memorial Health Systems - Martin Memorial Medical Center — Stuart, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Coliseum Medical Center — Macon, Georgia, United States
• Redmond Regional Medical Center — Rome, Georgia, United States
• Blessing Hospital — Quincy, Illinois, United States
• IU Health North Medical Center — Carmel, Indiana, United States
• Franciscan St. Francis Hospital — Indianapolis, Indiana, United States
• Community Heart and Vascular Hospital — Indianapolis, Indiana, United States
• St. Joseph Hospital — Lexington, Kentucky, United States
• Cardiovascular Research, LLC — Shreveport, Louisiana, United States
• Eastern Maine Medical Center — Bangor, Maine, United States
• Cape Cod Hospital — Hyannis, Massachusetts, United States
• Huntsville Hospital - The Heart Center, PC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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