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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01663896




Registration number
NCT01663896
Ethics application status
Date submitted
7/08/2012
Date registered
13/08/2012
Date last updated
2/07/2020

Titles & IDs
Public title
Observational Study of OCT in a Patients Undergoing FFR
Scientific title
Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)
Secondary ID [1] 0 0
SJM-CVD-0612
Universal Trial Number (UTN)
Trial acronym
ILUMIEN I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - OCT stent guidance

Single or multi vessel disease - Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants.


Treatment: Devices: OCT stent guidance
Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Timepoint [1] 0 0
In-hospital until discharge
Primary outcome [2] 0 0
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Timepoint [2] 0 0
30 Days
Primary outcome [3] 0 0
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
Timepoint [1] 0 0
1 Year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
418
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Austria
State/province [13] 0 0
Vienna
Country [14] 0 0
Belgium
State/province [14] 0 0
Aalst
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
China
State/province [17] 0 0
Hong Kong
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno
Country [19] 0 0
France
State/province [19] 0 0
Clermont-Ferrand
Country [20] 0 0
France
State/province [20] 0 0
Le Plessis Robinson
Country [21] 0 0
France
State/province [21] 0 0
Toulouse
Country [22] 0 0
Germany
State/province [22] 0 0
Munich
Country [23] 0 0
Italy
State/province [23] 0 0
Bergamo
Country [24] 0 0
Italy
State/province [24] 0 0
Milan
Country [25] 0 0
Italy
State/province [25] 0 0
Rome
Country [26] 0 0
Japan
State/province [26] 0 0
Hyogo
Country [27] 0 0
Japan
State/province [27] 0 0
Nara
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Wakayama
Country [30] 0 0
Netherlands
State/province [30] 0 0
Rotterdam
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
United Kingdom
State/province [32] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01663896
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01663896