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NCT01589978 · ClinicalTrials.gov registry record · Phase 4
PROMUS Element Plus US Post-Approval Study
A Phase 4 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,681
- Enrollment target
NCT01589978 is a Phase 4 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 2,681 participants.
The verdict
NCT01589978, a Phase 4 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,681 participants
- Enrollment target
Study 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.
Interventions
- DRUG Aspirin
- DEVICE PROMUS Element Plus Coronary Stent System
- DRUG P2Y12 antagonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,681 participants |
| Start Date | 2012-05 |
| Est. Completion | 2018-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01589978
The ClinicalTrials.gov registry entry for NCT01589978 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2,681 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Aspirin is the first listed.
NCT01589978 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01589978 about?
NCT01589978 is a clinical study titled "PROMUS Element Plus US Post-Approval Study". 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 con...
What is the current status of trial NCT01589978?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,681 participants. The study started on 2012-05. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01589978?
The interventions under investigation include: Aspirin (DRUG), PROMUS Element Plus Coronary Stent System (DEVICE), P2Y12 antagonist (DRUG).
Who is sponsoring clinical trial NCT01589978?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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