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PROMUS Element Plus US Post-Approval Study

NCT01589978 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2681

Last updated 2018-07-26

Study results available
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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.

Conditions

Interventions

DEVICE

PROMUS Element Plus Coronary Stent System

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).

DRUG

Aspirin

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.

DRUG

P2Y12 antagonist

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)

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Peter M Maurer, MPH · Boston Scientific Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-08-31
Completion
2018-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589978 on ClinicalTrials.gov