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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 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.

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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).

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

FieldValue
Enrollment Target 1,530 participants
Start Date 2009-01
Est. Completion 2014-12
Phase Phase 3

Sponsor

Boston Scientific Corporation

280 total trials

What the Registry Record Tells You About NCT00823212

The ClinicalTrials.gov registry entry for NCT00823212 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,530 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,280-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (20% higher). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.