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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: Completed Phase 4 study, sponsored by Boston Scientific Corporation.
NCT01589978 is a Phase 4 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 2,681 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (418% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and \<2.5 mm, or lesion length ≤24 mm with diamete
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 |
What the finished NCT01589978 record still lists
NCT01589978 is an interventional study that assigns participants to a tested intervention. Its 2,681 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (418% higher).
The record links to 0 conditions, and to 3 interventions - of which Aspirin is the first listed.
NCT01589978 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01589978's enrollment target sits among peer trials
2,681 27th of 2000 higher than 1,974 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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