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NCT01510327 · ClinicalTrials.gov registry record · Phase 3

PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)

A Phase 3 study, sponsored by Boston Scientific Corporation.

Completed
Registry status
Phase 3
Development phase
22
Enrollment target

NCT01510327: Completed Phase 3 study, sponsored by Boston Scientific Corporation.

NCT01510327 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 22 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01510327, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
Phase 3
Development phase
22 participants
Enrollment target

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 are located in vessels that are average-sized.

Primary Outcome

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent

Interventions

  • DRUG Aspirin
  • DRUG Thienopyridine
  • DEVICE PROMUS Element Everolimus-Eluting Coronary Stent System

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2009-10
Est. Completion 2015-05
Phase Phase 3
Boston Scientific Corporation

280 total trials

What the finished NCT01510327 record still lists

NCT01510327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 3 interventions - of which Aspirin is the first listed.

NCT01510327 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01510327 about?

NCT01510327 is a clinical study titled "PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)". 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 are located in vessels that are average-sized.

What is the current status of trial NCT01510327?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 22 participants. The study started on 2009-10. Estimated completion is 2015-05.

What interventions are being tested in trial NCT01510327?

The interventions under investigation include: Aspirin (DRUG), Thienopyridine (DRUG), PROMUS Element Everolimus-Eluting Coronary Stent System (DEVICE).

Who is sponsoring clinical trial NCT01510327?

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

How this trial's enrollment target compares

Where NCT01510327's enrollment target sits among peer trials

22 1953rd of 2000 higher than 48 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01510327, the US trial registry maintained by the National Library of Medicine. NCT01510327 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.