Overview

PROMUS Element Plus US Post-Approval Study

Status:
Completed

Trial end date:
2018-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Boston Scientific Corporation

Treatments:

Aspirin
Clopidogrel
Everolimus
Prasugrel Hydrochloride
Salicylates
Salicylic Acid
Sirolimus
Ticagrelor
Ticlopidine

Criteria

Inclusion Criteria:

- The population will include consecutive, consented patients.

Exclusion Criteria:

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