Clinical trial NCT01589978: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: drug-eluting stent
DES
atherosclerosis
everolimus
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 2681
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* The population will include consecutive, consented patients.

Exclusion Criteria:

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

Primary outcomes:
measure: Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients
timeFrame: 12 months
Secondary outcomes:
measure: Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients
timeFrame: 12 months
measure: Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Rate of Longitudinal Stent Deformation
timeFrame: Index Procedure
measure: Major Adverse Cardiac Event Rate (MACE)
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Myocardial Infarction (MI) Rate
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Cardiac Death Rate
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Rate of Cardiac Death Events Related to the PROMUS Element Stent
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Target Vessel Revascularization (TVR) Rate
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Cardiac Death or Myocardial Infarction (MI) Rate
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Target Vessel Failure (TVF) Rate
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: All Death Rate
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Non-cardiac Death Rate
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: All Death or Myocardial Infarction Rate
timeFrame: ≤24 hours, 30 days, 180 days, annually through 5 years
measure: Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients
timeFrame: 12 Months
measure: ARC ST Rate in PLATINUM-like Population.
timeFrame: Annually through 5 years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital - The Heart Center, PC
state: Alabama
city: Mobile
country: United States
facility: Springhill Medical Center
state: Alabama
city: Jonesboro
country: United States
facility: NEA Baptist Memorial Hospital
state: Arkansas
city: Jonesboro
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Brandon
country: United States
facility: Brandon Regional Hospital
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Panama City
country: United States
facility: Bay Medical Center
state: Florida
city: Stuart
country: United States
facility: Martin Memorial Health Systems - Martin Memorial Medical Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Macon
country: United States
facility: Coliseum Medical Center
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Quincy
country: United States
facility: Blessing Hospital
state: Illinois
city: Carmel
country: United States
facility: IU Health North Medical Center
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan St. Francis Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Community Heart and Vascular Hospital
state: Indiana
city: Lexington
country: United States
facility: St. Joseph Hospital
state: Kentucky
city: Shreveport
country: United States
facility: Cardiovascular Research, LLC
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Saint Joseph
country: United States
facility: Lakeland Hospitals at St. Joseph
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital - St. Paul Heart Clinic
state: Minnesota
city: Hattiesburg
country: United States
facility: Forest County General Hospital
state: Mississippi
city: Springfield
country: United States
facility: St. John's Regional Health Center (Springfield)
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Centers
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Utica
country: United States
facility: St. Elizabeth Medical Center
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: St. Francis Hospital
state: Oklahoma
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian University of Pennsylvania Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: University Medical Center-Greenville Memorial Hospital
state: South Carolina
city: Greenville
country: United States
facility: St. Francis Health System - St. Francis Hospital
state: South Carolina
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Heart Hospital of South Dakota
state: South Dakota
city: Austin
country: United States
facility: South Austin Hospital
state: Texas
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinics
state: Utah
city: Richmond
country: United States
facility: Chippenham Medical Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Madison
country: United States
facility: Meriter Hospital
state: Wisconsin
city: Weston
country: United States
facility: Marshfiled Clinic
state: Wisconsin
Study officials:
affiliation: Boston Scientific Corporation
name: Peter M Maurer, MPH
role: STUDY_DIRECTOR
References:
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.
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.