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

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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:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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.

Condition or disease Intervention/treatment
Coronary Artery Disease 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 Design
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Study Type : Observational
Actual Enrollment : 418 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)
Actual Study Start Date : December 11, 2012
Actual Primary Completion Date : March 12, 2015
Actual Study Completion Date : October 2015
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elective or ad hoc PCI, stable angina, acute coronary syndrome
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663896


Locations
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Sponsors and Collaborators
Abbott Medical Devices
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01663896    
Other Study ID Numbers: SJM-CVD-0612
First Posted: August 13, 2012    Key Record Dates
Results First Posted: July 2, 2020
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
OCT, FFR, percutaneous coronary intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases