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NCT00916370 · ClinicalTrials.gov registry record · Phase 3

SPIRIT PRIME Clinical Trial

A Phase 3 study, sponsored by Abbott Medical Devices.

Completed
Registry status
Phase 3
Development phase
525
Enrollment target

NCT00916370: Completed Phase 3 study, sponsored by Abbott Medical Devices.

NCT00916370 is a Phase 3 study that has completed, run by Abbott Medical Devices. The registered enrollment target is 525 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00916370, a Phase 3 study, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
Phase 3
Development phase
525 participants
Enrollment target

Study Summary

To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.

Primary Outcome

The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

Interventions

  • DEVICE Core size Xience Prime
  • DEVICE Xience Prime Long Lesion (LL)

Trial Details

FieldValue
Enrollment Target 525 participants
Start Date 2009-06
Est. Completion 2014-02
Phase Phase 3
Abbott Medical Devices

261 total trials

What the finished NCT00916370 record still lists

NCT00916370 is an interventional study that assigns participants to a tested intervention. The registered 525 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 2 interventions - of which Core size Xience Prime is the first listed.

NCT00916370 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00916370 about?

NCT00916370 is a clinical study titled "SPIRIT PRIME Clinical Trial". To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a ...

What is the current status of trial NCT00916370?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 525 participants. The study started on 2009-06. Estimated completion is 2014-02.

What interventions are being tested in trial NCT00916370?

The interventions under investigation include: Core size Xience Prime (DEVICE), Xience Prime Long Lesion (LL) (DEVICE).

Who is sponsoring clinical trial NCT00916370?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00916370's enrollment target sits among peer trials

525 715th of 2000 higher than 1,285 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 NCT00916370, the US trial registry maintained by the National Library of Medicine. NCT00916370 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.