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NCT00823212 · ClinicalTrials.gov registry record · Phase 3
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions
A Phase 3 study of Coronary Artery Disease, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,530
- Enrollment target
- 20
- Study locations
NCT00823212: Completed Phase 3 study of Coronary Artery Disease, sponsored by Boston Scientific Corporation.
NCT00823212 is a Phase 3 study of Coronary Artery Disease that has completed, run by Boston Scientific Corporation. The registered enrollment target is 1,530 participants, above the 1,280-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00823212, a Phase 3 study of Coronary Artery Disease, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,530 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).
Primary Outcome
Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Conditions Studied
Interventions
- DRUG Aspirin
- DEVICE PROMUS Element Coronary Stent System
- DEVICE PROMUS Coronary Stent System
- DRUG Thienopyridine
Study Locations (20)
California
- Bakersfield Memorial Hospital - Bakersfield
- Scripps Clinic - La Jolla
- Good Samaritan Hospital - Los Angeles
- University of California Davis Medical Center - Sacramento
- Mercy General Hospital - Sacramento
- University of California San Diego - San Diego
- Alvarado Hospital - San Diego
Florida
- Holy Cross Hospital - Fort Lauderdale
- MediQuest Research Group Inc. at Munroe Regional Medical Center - Ocala
- Florida Hospital - Orlando
- Tallahassee Memorial Hospital - Tallahassee
Colorado
- South Denver Cardiology Associates, PC - Littleton
- Medical Center of the Rockies (Loveland) - Loveland
Illinois
- Southern Illinois University Memorial Medical Center - Springfield
- St. John's Hospital - Springfield
Alabama
- Baptist Medical Center Princeton - Birmingham
Arizona
- Banner Good Samaritan Regional Medical Center - Phoenix
Arkansas
- Arkansas Heart Hospital - Little Rock
Georgia
- Medical Center of Central Georgia - Macon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,530 participants |
| Start Date | 2009-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT00823212 record still lists
NCT00823212 is an interventional study that assigns participants to a tested intervention. Its 1,530 participants enrollment target places it among the larger protocols in the corpus, above the 1,280-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 4 interventions - of which Aspirin is the first listed.
NCT00823212 names 20 study sites across 9 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT00823212 about?
NCT00823212 is a clinical study titled "The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions". The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. This clinical trial compares outcomes in patients treated with PROMUS Ele...
What is the current status of trial NCT00823212?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,530 participants. The study started on 2009-01. Estimated completion is 2014-12.
What conditions does trial NCT00823212 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT00823212?
The interventions under investigation include: Aspirin (DRUG), PROMUS Element Coronary Stent System (DEVICE), PROMUS Coronary Stent System (DEVICE), Thienopyridine (DRUG).
Who is sponsoring clinical trial NCT00823212?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00823212 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00823212's enrollment target sits among peer trials
1,530 35th of 219 higher than 185 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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.
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