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NCT02471586 · ClinicalTrials.gov registry record · NA
OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation
A NA study of Coronary Artery Disease, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT02471586: Completed NA study of Coronary Artery Disease, sponsored by Abbott Medical Devices.
NCT02471586 is a NA study of Coronary Artery Disease that has completed, run by Abbott Medical Devices. The registered enrollment target is 450 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02471586, a NA study of Coronary Artery Disease, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation
Primary Outcome
Post-PCI MSA will be assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Hierarchal manner testing will be as follows: 1. Non-inferiority: OCT vs. IVUS guided stenting Non-inferiority of OCT guided stenting to IVUS guided stenting will be analyzed for the mean difference between the post PCI MSA for the OCT and IVUS arms with non-inferiority margin of 1.0 mm\^2. 2. Superiority: OCT vs. Angiography guided stenting
Conditions Studied
Interventions
- PROCEDURE Coronary PCI guided by IVUS
- PROCEDURE Coronary PCI guided by OCT
- PROCEDURE Coronary PCI guided by Angiography
Study Locations (20)
New York
- New York Presbyterian Hospital/Columbia University - New York
- Lenox Hill Hospital - New York
- St. Francis Hospital - Roslyn
Texas
- Austin Heart - Austin
- Memorial Hermann Hospital - Houston
- The University of Texas Health Science at San Antonio - San Antonio
Alabama
- University Hospital - Univ. of Alabama at Birmingham (UAB) - Birmingham
Arizona
- Scottsdale Healthcare Shea - Scottsdale
California
- University of California at San Diego (UCSD) Medical Center - San Diego
Colorado
- Heart Institute of Colorado - Broomfield
Florida
- Orlando Health - Orlando
Georgia
- Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2015-05 |
| Est. Completion | 2017-04-25 |
| Phase | NA |
What the finished NCT02471586 record still lists
NCT02471586 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 3 interventions - of which Coronary PCI guided by IVUS is the first listed.
NCT02471586 names 20 study sites across 16 states, led by New York, Texas, Alabama.
Frequently Asked Questions
What is clinical trial NCT02471586 about?
NCT02471586 is a clinical study titled "OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation". The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation
What is the current status of trial NCT02471586?
This trial is currently completed. It is a NA study. The enrollment target is 450 participants. The study started on 2015-05. Estimated completion is 2017-04-25.
What conditions does trial NCT02471586 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT02471586?
The interventions under investigation include: Coronary PCI guided by IVUS (PROCEDURE), Coronary PCI guided by OCT (PROCEDURE), Coronary PCI guided by Angiography (PROCEDURE).
Who is sponsoring clinical trial NCT02471586?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02471586 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02471586's enrollment target sits among peer trials
450 79th of 219 higher than 140 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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