PROMUS Element Plus US Post-Approval Study



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/27/2018
Start Date:May 2012
End Date:June 2018

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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.

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.

Inclusion Criteria:

- The population will include consecutive, consented patients.

Exclusion Criteria:

- There are no exclusion criteria in this all-comers study.
We found this trial at
52
sites
Minneapolis, Minnesota 55422
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1414 Kuhl Avenue
Orlando, Florida 32806
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Orlando, FL
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Atlanta, GA
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Austin, Texas 78745
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Austin, TX
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489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Bangor, ME
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Brandon, Florida 33511
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Brandon, FL
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Carmel, Indiana 46032
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Carmel, IN
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Charlotte, North Carolina 28204
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Charlotte, NC
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Dallas, Texas 75231
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Dallas, TX
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Dallas, Texas 75216
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Doylestown, Pennsylvania 18901
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Gainesville, Florida 32605
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Gainesville, FL
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Greenville, SC
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Greenville, South Carolina 29607
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hattiesburg, Mississippi 39401
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Hollywood, Florida 33021
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Hollywood, FL
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Huntsville, Alabama 35801
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Hyannis, Massachusetts 02601
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Indianapolis, Indiana 46237
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Indianapolis, Indiana 46250
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Jonesboro, Arkansas 72401
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Jonesboro, Arkansas 72401
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Lexington, Kentucky 40504
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Macon, Georgia 31217
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Madison, Wisconsin 53715
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Miami Beach, Florida 33140
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3719 Dauphin Street
Mobile, Alabama 36608
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Mobile, AL
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Myrtle Beach, South Carolina 29572
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Myrtle Beach, SC
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New York, New York 10021
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New York, NY
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Newark, Delaware 19718
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Panama City, Florida 32401
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Panama City, FL
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Philadelphia, PA
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Quincy, Illinois 62301
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Quincy, IL
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Richmond, Virginia 23225
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Roanoke, Virginia 24033
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Rome, Georgia 30165
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Sacramento, California 95819
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Saint Joseph, Michigan 49085
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Saint Paul, Minnesota 55102
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Salt Lake City, Utah 84132
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Shreveport, Louisiana 71105
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Sioux Falls, South Dakota 57108
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Springfield, Missouri 65807
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Stuart, FL
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Tulsa, Oklahoma 74136
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Utica, New York 13501
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3501 Cranberry Boulevard
Weston, Wisconsin 55476
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Weston, WI
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