ILUMIEN IV: OPTIMAL PCI
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atherosclerosis
- Coronary (Artery) Disease
- Coronary Stenosis
- NSTEMI - Non-ST Segment Elevation MI
- (STEMI)
- STEMI - ST Elevation Myocardial Infarction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a prospective, single-blind clinical investigation randomizing subjects to OCT-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio. The clinical investigation will be conducted at approximately 125 centers in North America (US and Canada), Eur...
This is a prospective, single-blind clinical investigation randomizing subjects to OCT-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio. The clinical investigation will be conducted at approximately 125 centers in North America (US and Canada), Europe, Middle East and Asia-Pacific. All patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups. After hospital discharge, all patients will have clinical follow-up at 30 days, 1 year, and 2 years.
Tracking Information
- NCT #
- NCT03507777
- Collaborators
- Abbott
- Investigators
- Study Chair: Gregg W Stone, MD NewYork-Presbyterian/Columbia University Medical Center Principal Investigator: Ulf Landmesser, MD Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF) Principal Investigator: Ziad A Ali, MD, DPhil NewYork-Presbyterian/Columbia University Medical Center
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