Observational Study of OCT in a Patients Undergoing FFR (ILUMIEN I)

• ClinicalTrials.gov Identifier: NCT01663896
• Recruitment Status: Completed
• First Posted: August 13, 2012
• Results First Posted: July 2, 2020
• Last Update Posted: July 2, 2020
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: August 7, 2012
• First Posted Date: August 13, 2012
• Results First Submitted Date: June 22, 2016
• Results First Posted Date: July 2, 2020
• Last Update Posted Date: July 2, 2020
• Actual Study Start Date: December 11, 2012
• Actual Primary Completion Date: March 12, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2020)

• Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting [ Time Frame: In-hospital until discharge ]
  Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
• Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting [ Time Frame: 30 Days ]
  Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
• Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) [ Time Frame: 12 months ]
  Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months

• Original Primary Outcome Measures (submitted: August 9, 2012): Identify OCT peri-procedural guidance parameter(s) for stent implantation that relates with patient outcomes in the hospital, at 30 days, and 12 months post intervention. [ Time Frame: participants will be followed from their hospital stay until 12 months after ]

Current Secondary Outcome Measures (submitted: June 17, 2020)

Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT [ Time Frame: 1 Year ]

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

Original Secondary Outcome Measures (submitted: August 9, 2012)

• Correlation/relationship of OCT parameters, as defined by OCT volumetric analysis, on pre and post intervention FFR values. [ Time Frame: participants will be followed from their hospital stay until 12 months after ]
• Consideration of health economics data and resource utilization. [ Time Frame: participants will be followed from their hospital stay until 12 months after ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Observational Study of OCT in a Patients Undergoing FFR
• Official Title: Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)
• 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.

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
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Elective or ad hoc PCI, stable angina, acute coronary syndrome
• Condition: Coronary Artery Disease

Intervention

Device: OCT stent guidance

Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT

Study Groups/Cohorts

Single or multi vessel disease

Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants.

Intervention: Device: OCT stent guidance

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 21, 2015): 418
• Original Estimated Enrollment (submitted: August 9, 2012): 500
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: March 12, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT01663896
• Other Study ID Numbers: SJM-CVD-0612
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Same as current
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Abbott Medical Devices
• Verification Date: June 2020