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NCT01498692 · ClinicalTrials.gov registry record · NA

The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels

A NA study of Coronary Artery Disease, sponsored by Boston Scientific Corporation.

Completed
Registry status
NA
Development phase
94
Enrollment target
20
Study locations

NCT01498692: Completed NA study of Coronary Artery Disease, sponsored by Boston Scientific Corporation.

NCT01498692 is a NA study of Coronary Artery Disease that has completed, run by Boston Scientific Corporation. The registered enrollment target is 94 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01498692, a NA study of Coronary Artery Disease, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
NA
Development phase
94 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. The lesions can be located in vessels that are smaller than average-sized.

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. The primary analysis set for the non-inferiority testing of the primary endpoint is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.

Conditions Studied

Interventions

  • DEVICE PROMUS Element Coronary Stent System

Study Locations (20)

Other

  • Monash Medical Centre - Clayton
  • Ziekenhuis Oost Limburg - Genk
  • UZ Gasthuisberg - Leuven
  • Clinique Pasteur - Toulouse

Florida

  • Mediquest Research at Munroe Regional Medical Center - Ocala
  • Florida Hospital - Orlando

North Carolina

  • Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation - Greensboro
  • Wake Medical Center - Raleigh

Ohio

  • Lindner Center for Research and Education at The Christ Hospital - Cincinnati
  • Ohio Health Research and Innovation Institute - Columbus

Texas

  • Baylor Heart & Vascular Hospital - Dallas
  • TexSAn Heart Hospital - San Antonio

California

  • Bakersfield Memorial Hospital - Bakersfield

Illinois

  • St. John's Hospital - Springfield

Kentucky

  • Jewish Hospital & St. Mary's Healthcare - Louisville

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2009-02
Est. Completion 2015-05
Phase NA
Boston Scientific Corporation

280 total trials

What the finished NCT01498692 record still lists

NCT01498692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (93% lower).

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which PROMUS Element Coronary Stent System is the first listed.

NCT01498692 names 20 study sites across 13 states, led by Other, Florida, North Carolina.

Frequently Asked Questions

What is clinical trial NCT01498692 about?

NCT01498692 is a clinical study titled "The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels". 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. The lesions can be located in vessels that are smaller than average-sized.

What is the current status of trial NCT01498692?

This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2009-02. Estimated completion is 2015-05.

What conditions does trial NCT01498692 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

What interventions are being tested in trial NCT01498692?

The interventions under investigation include: PROMUS Element Coronary Stent System (DEVICE).

Who is sponsoring clinical trial NCT01498692?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01498692 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Coronary Artery Disease

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 NCT01498692's enrollment target sits among peer trials

94 152nd of 219 higher than 68 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01498692, the US trial registry maintained by the National Library of Medicine. NCT01498692 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.