ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)

Not Applicable

Completed

• Conditions: Atherosclerosis; STEMI - ST Elevation Myocardial Infarction; NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI); Coronary Stenosis; Coronary Artery Disease; STEMI

• Registration Number: NCT03507777
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-15
• Study First Posted: 2018-04-25
• Study Start: 2018-05-17
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Results First Submitted: 2024-02-27
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Results First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2487

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Imaging Outcome (Powered): Minimal Stent Area (MSA)	Final Post-PCI Measurement (average of 24 hours).	Minimal Stent Area (per target lesion basis) assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.
Number of Participants With Target Vessel Failure (TVF)	At 2 years	Time-to-first event rate of the composite outcome of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR), will be assessed.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Target Vessel Failure (TVF) Excluding Periprocedural MI (Powered)	At 2 years	Time-to-first event rate of composite outcome of cardiac death, target vessel-related spontaneous myocardial infarction, or ischemia-driven target vessel revascularization (ID-TVR) will be assessed.
The Number of Participants With Stent Thrombosis	2 years	The results of adjudicated clinical outcomes to 2 years in the randomized population by Kaplan-Meier assessment.
The Results of Adjudicated Clinical Outcomes to 2 Years in the Randomized Population	2 years	The results of adjudicated clinical outcomes to 2 years in the randomized population by Kaplan-Meier assessment.

Trial Locations

Locations (90)

University Hospital - Univ. of Alabama at Birmingham (UAB); 🇺🇸 Birmingham, Alabama, United States

Scottsdale Healthcare Shea; 🇺🇸 Scottsdale, Arizona, United States

Mills-Peninsula Medical Center; 🇺🇸 Burlingame, California, United States

John Muir Medical Center; 🇺🇸 Concord, California, United States

Scripps Health; 🇺🇸 La Jolla, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California - Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of California at San Diego (UCSD) Medical Center; 🇺🇸 San Diego, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

The Cardiac & Vascular Institute Research Foundation, LLC; 🇺🇸 Gainesville, Florida, United States

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