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)

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: OCT stent guidance

Detailed Description

Optical coherence tomography (OCT) is an imaging modality that uses near-infrared light to produce high resolution, real-time images that are clearer and more quickly produced than those produced by intravascular ultrasound (IVUS). OCT imaging is performed utilizing an imaging catheter with a single optical fiber core that both emits light and records its reflection while simultaneously rotating 360° during continuous pullback within the coronary artery. Fractional Flow Reserve (FFR) is a pressure-derived, lesion-specific, physiological index determining the hemodynamic severity of intracoronary lesions. FFR is measured by placing a pressure guidewire across the lesion of interest and pharmacologically inducing hyperemia. The ratio of distal to proximal pressure allows the physician to physiologically determine if the narrowing is the cause of ischemia. the goal of this study is to define new parameters for stent optimization, benefitting from the unique Fourier-domain (FD-OCT) capabilities.

This stage I study will identify the parameters which will be prospectively tested in a second stage II protocol.

In hospital, 30 day, and 12 month outcomes data will be correlated with OCT baseline findings in order to identify optimal stent implant parameters.

• Study Type: Observational
• Enrollment (Actual): 418

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Chermside, Queensland, Australia
      • The Prince Charles Hospital
• Austria
  • Vienna, Austria
    • Med. Univ. Vienna
• Belgium
  • Aalst, Belgium
    • OLV Hospital
  • Leuven, Belgium
    • Gasthuisberg Leuven
• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Montreal Heart Institute
• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • University of Hong Kong
• Czechia
  • Brno, Czechia
    • University Hospital Brno
• France
  • Clermont-Ferrand, France
    • CHU Clermont Ferrand
  • Le Plessis Robinson, France
    • CHC du Marie Lannelongue
  • Toulouse, France
    • Clinique Pasteur
• Germany
  • Munich, Germany
    • Deutsches Herzzentrum
• Italy
  • Bergamo, Italy
    • Ospedali Riuniti di Bergamo
  • Milan, Italy
    • Centro Cardiologico Monzino
  • Rome, Italy
    • Ospedale San Giovanni Addolorata
• Japan
  • Hyogo, Japan
    • Kobe University Graduate School of Medicine
  • Nara, Japan
    • Nara Medical University Hospital
  • Osaka, Japan
    • Osaka Saiseikai Nakatsu Hospital
  • Wakayama, Japan
    • Wakayama Medical University
• Netherlands
  • Rotterdam, Netherlands
    • Thoraxcentre Erasmus MC
• Spain
  • Madrid, Spain
    • Hospital Univ. Clinico San Carlos
• United Kingdom
  • London, United Kingdom
    • Royal Brompton Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University Hospital - Univ. of Alabama at Birmingham (UAB)
  • California
    • La Jolla, California, United States
      • Scripps Clinic, Green Hospital
  • Florida
    • Orlando, Florida, United States
      • Florida Hospital Orlando
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Chicago
  • Kentucky
    • Lexington, Kentucky, United States
      • Central Baptist Hospital
    • Louisville, Kentucky, United States
      • Baptist Health East
  • Missouri
    • Kansas City, Missouri, United States
      • St. Luke's Hospital/Mid America Heart
  • New Jersey
    • New Brunswick, New Jersey, United States
      • Rutgers Cardiovascular Institute
  • New York
    • New York, New York, United States
      • Mount Sinai Medical Center
  • Texas
    • Austin, Texas, United States
      • Heart Hospital of Austin
    • Dallas, Texas, United States
      • Dallas VA Medical Center
    • Galveston, Texas, United States
      • University of Texas Medical Branch at Galveston
  • Washington
    • Seattle, Washington, United States
      • Swedish Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elective or ad hoc PCI, stable angina, acute coronary syndrome

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient provides signed written informed consent before any study-specific procedure.
3. De novo coronary artery disease in target vessel.
4. 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.
5. Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and NSTEMI).
6. Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery.
7. Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects with an FFR ≤ 0.80 in target vessel.

Exclusion Criteria:

1. Subjects with STEMI, emergent PCI, or in cardiogenic shock.
2. Subjects with target left main lesion.
3. Subjects with restenosis or stent thrombosis in the target vessel.
4. Planned use of bare metal stent.
5. Known renal insufficiency (examples being but not limited to eGFR < 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).
6. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
7. Extreme angulation (> 90°) or excessive tortuosity (> two 45° angles) proximal to or within the target lesion.
8. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
9. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
10. Currently participating in another clinical study that interferes with study results.
11. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
12. Life expectancy less than 1 year.
13. Potential for non-compliance to protocol requirements and follow-up.
14. Planned or prior heart transplantation or listed for heart transplant.
15. Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single or multi vessel disease; Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants.	Device: OCT stent guidance; Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT	Assessment of OCT on Physician Decision Making includes: Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment; OCT parameters as assessed by Core Lab	1 Year

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2012
• Primary Completion (Actual): March 12, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimate): August 13, 2012

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: OCT, FFR, percutaneous coronary intervention
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: SJM-CVD-0612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO