Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments promus element plus coronary stent system, aspirin, p2y12 antagonist
Phase phase 4
Sponsor Boston Scientific Corporation
Start date May 2012
End date September 2014
Trial size 2689 participants
Trial identifier NCT01589978, S2066

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
promus element plus coronary stent system PROMUS Element stent
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).
aspirin Acetyl salicylic acid
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.
p2y12 antagonist PLAVIX (clopidogrel)
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 Outcomes

Measure
Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients
time frame: 12 months

Secondary Outcomes

Measure
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients
time frame: 12 months
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Longitudinal Stent Deformation
time frame: Index Procedure
Major Adverse Cardiac Event Rate (MACE)
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Myocardial Infarction (MI) Rate
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Cardiac Death Rate
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Cardiac Death Events Related to the PROMUS Element Stent
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target Vessel Revascularization (TVR) Rate
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Cardiac Death or Myocardial Infarction (MI) Rate
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target Vessel Failure (TVF) Rate
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
All Death Rate
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Non-cardiac Death Rate
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
All Death or Myocardial Infarction Rate
time frame: ≤24 hours, 30 days, 180 days, annually through 5 years
Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients
time frame: 12 Months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - The population will include consecutive, consented patients. Exclusion Criteria: - There are no exclusion criteria in this all-comers study.

Additional Information

Official title A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.