PROMUS Element Plus US Post-Approval Study

Boston Scientific

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: P2Y12 antagonist; Drug: Aspirin; Device: PROMUS Element Plus Coronary Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01589978

S2066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,681 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The population will include consecutive, consented patients.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,681 participants in 1 patient group

PROMUS Element

Experimental group

Description:

Subjects who receive the PROMUS Element everolimus-eluting coronary stent

Treatment:

Device: PROMUS Element Plus Coronary Stent System

Drug: Aspirin

Drug: P2Y12 antagonist