ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
- Conditions
- AtherosclerosisSTEMI - ST Elevation Myocardial InfarctionNSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)Coronary StenosisCoronary Artery DiseaseSTEMI
- Interventions
- Device: Coronary PCI guided by OCTDevice: Coronary PCI guided by Angiography
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2487
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coronary PCI guided by OCT Coronary PCI guided by OCT Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by Angiography Coronary PCI guided by Angiography Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
- 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 Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
University of California at San Diego (UCSD) Medical Center
🇺🇸San Diego, California, United States
Via Christi Regional Medical Center - St. Francis Campus
🇺🇸Wichita, Kansas, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
Apollo Hospital
🇮🇳Chennai, Tamil Nadu, India
Centennial Heart Cardiovascular Consultants
🇺🇸Nashville, Tennessee, United States
University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Scripps Health
🇺🇸La Jolla, California, United States
Eastern Cardiology
🇺🇸Greenville, North Carolina, United States
Royal Jubilee Hospital
🇨🇦Victoria, British Columbia, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Hopital du Sacre-Coeur de Montreal
🇨🇦Montréal, Quebec, Canada
Skejby University Hospital
🇩🇰Arhus, Denmark
Hopital Cardiovasculaire et Pneumologique Louis Pradel
🇫🇷Lyon, Rhone-Alpes, France
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Rhinela, Germany
Policlinico Universitario A. Gemelli
🇮🇹Roma, Latium, Italy
Max Super Specialty Hospital
🇮🇳New Delhi, India
Centro Cardiologico Monzino
🇮🇹Milano, Lombard, Italy
Sahlgrenska University Hospital - Gothenburg
🇸🇪Gothenburg, Vastra, Sweden
Papworth Hospital NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
University of California - Davis Medical Center
🇺🇸Sacramento, California, United States
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Mills-Peninsula Medical Center
🇺🇸Burlingame, California, United States
John Muir Medical Center
🇺🇸Concord, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
University of Massachusetts Medical Center
🇺🇸Worcester, Massachusetts, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Mission Health & Hospitals
🇺🇸Asheville, North Carolina, United States
New York Presbyterian Hospital/Columbia University
🇺🇸New York, New York, United States
St. Charles Medical Center
🇺🇸Bend, Oregon, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
McKay-Dee Heart Services
🇺🇸Ogden, Utah, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Providence Everett Medical Center
🇺🇸Everett, Washington, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Eastern Heart Clinic - Prince of Wales Hospital
🇦🇺Randwick, Australia
Hamilton Health Science Centre
🇨🇦Hamilton, Ontario, Canada
CHU Gabriel Montpied
🇫🇷Clermont-Ferrand, Auvergn, France
CHU de Besancon - Jean Minjoz
🇫🇷Besançon, Franche-Comte, France
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
🇩🇪Berlin, Germany
The Madras Medical Mission
🇮🇳Chennai, Tamil Nadu, India
Az. Osp. S. Giovanni Addolorata
🇮🇹Roma, Latium, Italy
Ospedale Papa Giovanni XXIII
🇮🇹Bergamo, Lombard, Italy
Christchurch Hospital
🇳🇿Christchurch, Canterbury, New Zealand
Wellington Hospital
🇳🇿Wellington, New Zealand
Bristol Royal Infirmary
🇬🇧Bristol, West Midland, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Onze-Lieve-Vrouwziekenhuis Campus Aalst
🇧🇪Aalst, Eflndrs, Belgium
Wakayama Medical University
🇯🇵Wakayama, Japan
Center Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
Kliniken der Friedrich-Alexander-Universitat
🇩🇪Erlangen, Bavaria, Germany
Hospital Santa Marta
🇵🇹Lisboa, Lisbon, Portugal
Queen Elizabeth Hospital
ðŸ‡ðŸ‡°Hong Kong, Hk Sar, Hong Kong
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hk Sar, Hong Kong
QE II Health Sciences
🇨🇦Halifax, Nova Scotia, Canada
CHUM
🇨🇦Montreal, Quebec, Canada
Klinikum der Justus-Liebig-Universität
🇩🇪Giessen, Hesse, Germany
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Zuid-Holland, Netherlands
National University Hospital
🇸🇬Singapore, Central, Singapore
Swedish Medical Center
🇺🇸Seattle, Washington, United States
UZ Gasthuisberg
🇧🇪Leuven, Flemish Brabant, Belgium
Postgraduate Institute of Medical Education & Research
🇮🇳Chandigarh, India
Luzerner Kantonsspital
🇨ðŸ‡Luzern, Switzerland
St. Patrick Hospital
🇺🇸Missoula, Montana, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Scottsdale Healthcare Shea
🇺🇸Scottsdale, Arizona, United States
Maasstad Ziekenhuis
🇳🇱Rotterdam, South Holland, Netherlands
Taipei Veterans General Hospital (VGH)
🇨🇳Taipei, Ntaiwan, Taiwan
Deutsches Herzzentrum München des Freistaates Bayern
🇩🇪Munich, Bavaria, Germany
National Taiwan University Hospital
🇨🇳Taipei, Ntaiwan, Taiwan
Austin Heart
🇺🇸Austin, Texas, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Montefiore Medical Center - Moses Division
🇺🇸Bronx, New York, United States
The Cardiac & Vascular Institute Research Foundation, LLC
🇺🇸Gainesville, Florida, United States
Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hk Sar, Hong Kong