Coronary Artery DiseaseILUMIEN INCT01663896
Observational Study of OCT in a Patients Undergoing FFR
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 36 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- OCT stent guidance
- Type of treatment
- Medical device
- How many people
- 418 participants
- Where
- 36 sitesin 14 countries
- Study dates
- 11 Dec 2012to Oct 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective or ad hoc PCI, stable angina, acute coronary syndrome
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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.
Trial locations and contacts
36 sites in 14 countries.
36 sites in 14 countries
United States15 sites
Emory University Hospital
Atlanta, Georgia
Heart Hospital of Austin
Austin, Texas
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233
Dallas VA Medical Center
Dallas, Texas
University of Texas Medical Branch at Galveston
Galveston, Texas
St. Luke's Hospital/Mid America Heart
Kansas City, Missouri
Scripps Clinic, Green Hospital
La Jolla, California
Central Baptist Hospital
Lexington, Kentucky
Baptist Health East
Louisville, Kentucky
Loyola University Chicago
Maywood, Illinois, 60153
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin
Rutgers Cardiovascular Institute
New Brunswick, New Jersey
Mount Sinai Medical Center
New York, New York
Florida Hospital Orlando
Orlando, Florida
Swedish Medical Center
Seattle, Washington
Japan4 sites
Kobe University Graduate School of Medicine
Hyōgo
Nara Medical University Hospital
Nara
Osaka Saiseikai Nakatsu Hospital
Osaka
Wakayama Medical University
Wakayama
France3 sites
CHU Clermont Ferrand
Clermont-Ferrand
CHC du Marie Lannelongue
Le Plessis-Robinson
Clinique Pasteur
Toulouse
Italy3 sites
Ospedali Riuniti di Bergamo
Bergamo
Centro Cardiologico Monzino
Milan
Ospedale San Giovanni Addolorata
Rome
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- OCT stent guidance
- Keywords
- OCT, FFR, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT stent guidanceDevice
Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT
| Study group | Role | What they receive |
|---|---|---|
| Single or multi vessel disease | Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants. Receives: Device: OCT stent guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (1)
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
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study start11 Dec 2012
- Primary completion12 Mar 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663896
- Sponsor's protocol ID
- SJM-CVD-0612
- Acronym
- ILUMIEN I
- Status last verified
- Jun 2020
- First submitted
- 7 Aug 2012
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 26242713
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)
- ClinicalTrials.gov ID
- NCT01663896
- Acronym / sponsor ID
- ILUMIEN I / SJM-CVD-0612
- Conditions
- Coronary Artery Disease
- Keywords
- OCT, FFR, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2012 (actual)
- Primary completion
- 12 Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Posted 2 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single or multi vessel disease | – | Device: OCT stent guidancePre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective or ad hoc PCI, stable angina, acute coronary syndrome
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT stent guidanceParticipants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT | Device | Single or multi vessel disease |
Primary outcome
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
1 secondary outcome
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26242713Wijns 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.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 36 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Japan, France, Italy, Belgium and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (time frame: In-hospital until discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01663896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.