At a glance
ClinicalIndex Comparison RecordN/ACompleted· 418 enrolled
Drug / intervention
OCT stent guidancedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)
In Brief
An observational study evaluating OCT stent guidance for Coronary Artery Disease. Completed, enrolled 418 participants across 36 sites in 14 countries.
Detailed Summary
The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesAustralia, Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartDec 2012
Primary CompletionMar 2015
Study CompletionOct 2015
TodayJul 2026
First PostedAug 13, 2012
Enrollment StartDec 11, 2012
Primary CompletionMar 12, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.9 years ago
Interventions
OCT stent guidancedevice
Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT