Observational Study of OCT in a Patients Undergoing FFR
ILUMIEN I
Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)
1 other identifier
observational
418
13 countries
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Typical duration for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedStudy Start
First participant enrolled
December 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
July 2, 2020
CompletedJuly 2, 2020
June 1, 2020
2.2 years
August 7, 2012
June 22, 2016
June 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
In-hospital until discharge
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
30 Days
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months
12 months
Secondary Outcomes (1)
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
1 Year
Study Arms (1)
Single or multi vessel disease
Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants.
Interventions
Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT
Eligibility Criteria
Elective or ad hoc PCI, stable angina, acute coronary syndrome
You may qualify if:
- Age ≥ 18 years.
- Patient provides signed written informed consent before any study-specific procedure.
- De novo coronary artery disease in target vessel.
- Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated, with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
- Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and NSTEMI).
- Angiographically significant (\>50% visual estimation) stenosis present in at least one native coronary artery.
- Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects with an FFR ≤ 0.80 in target vessel.
You may not qualify if:
- Subjects with STEMI, emergent PCI, or in cardiogenic shock.
- Subjects with target left main lesion.
- Subjects with restenosis or stent thrombosis in the target vessel.
- Planned use of bare metal stent.
- Known renal insufficiency (examples being but not limited to eGFR \< 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).
- Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- Extreme angulation (\> 90°) or excessive tortuosity (\> two 45° angles) proximal to or within the target lesion.
- Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
- Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
- Currently participating in another clinical study that interferes with study results.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
- Life expectancy less than 1 year.
- Potential for non-compliance to protocol requirements and follow-up.
- Planned or prior heart transplantation or listed for heart transplant.
- Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233, United States
Scripps Clinic, Green Hospital
La Jolla, California, United States
Florida Hospital Orlando
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Baptist Health East
Louisville, Kentucky, United States
St. Luke's Hospital/Mid America Heart
Kansas City, Missouri, United States
Rutgers Cardiovascular Institute
New Brunswick, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
Heart Hospital of Austin
Austin, Texas, United States
Dallas VA Medical Center
Dallas, Texas, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
The Prince Charles Hospital
Chermside, Queensland, Australia
Med. Univ. Vienna
Vienna, Austria
OLV Hospital
Aalst, Belgium
Gasthuisberg Leuven
Leuven, Belgium
Montreal Heart Institute
Montreal, Quebec, Canada
University of Hong Kong
Hong Kong, Hong Kong, China
University Hospital Brno
Brno, Czechia
CHU Clermont Ferrand
Clermont-Ferrand, France
CHC du Marie Lannelongue
Le Plessis-Robinson, France
Clinique Pasteur
Toulouse, France
Deutsches Herzzentrum
Munich, Germany
Ospedali Riuniti di Bergamo
Bergamo, Italy
Centro Cardiologico Monzino
Milan, Italy
Ospedale San Giovanni Addolorata
Rome, Italy
Kobe University Graduate School of Medicine
Hyōgo, Japan
Nara Medical University Hospital
Nara, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Japan
Wakayama Medical University
Wakayama, Japan
Thoraxcentre Erasmus MC
Rotterdam, Netherlands
Hospital Univ. Clinico San Carlos
Madrid, Spain
Royal Brompton Hospital
London, United Kingdom
Related Publications (1)
Wijns W, Shite J, Jones MR, Lee SW, Price MJ, Fabbiocchi F, Barbato E, Akasaka T, Bezerra H, Holmes D. Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study. Eur Heart J. 2015 Dec 14;36(47):3346-55. doi: 10.1093/eurheartj/ehv367. Epub 2015 Aug 4.
PMID: 26242713DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Patients with acute STEMI, left main PCI, severe chronic kidney disease, and other high-risk features were excluded. No prescriptive recommendations were provided in the protocol, a wide variation in physician behavior was expected and observed.
Results Point of Contact
- Title
- Sr. Manager, Global Clinical Affairs
- Organization
- St. Jude Medical
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 13, 2012
Study Start
December 11, 2012
Primary Completion
March 12, 2015
Study Completion
October 1, 2015
Last Updated
July 2, 2020
Results First Posted
July 2, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share