Clinical trial NCT01663896: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: OCT, FFR, percutaneous coronary intervention
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective or ad hoc PCI, stable angina, acute coronary syndrome

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.

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.

Primary outcomes:
measure: Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
timeFrame: In-hospital until discharge
measure: Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
timeFrame: 30 Days
measure: Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
timeFrame: 1 Year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital - Univ. of Alabama at Birmingham (UAB)
state: Alabama
city: La Jolla
country: United States
facility: Scripps Clinic, Green Hospital
state: California
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health East
state: Kentucky
city: Kansas City
country: United States
facility: St. Luke's Hospital/Mid America Heart
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Cardiovascular Institute
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Vienna
country: Austria
facility: Med. Univ. Vienna
city: Aalst
country: Belgium
facility: OLV Hospital
city: Leuven
country: Belgium
facility: Gasthuisberg Leuven
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Hong Kong
country: China
facility: University of Hong Kong
state: Hong Kong
city: Brno
country: Czechia
facility: University Hospital Brno
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Le Plessis Robinson
country: France
facility: CHC du Marie Lannelongue
city: Toulouse
country: France
facility: Clinique Pasteur
city: Munich
country: Germany
facility: Deutsches Herzzentrum
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Rome
country: Italy
facility: Ospedale San Giovanni Addolorata
city: Hyogo
country: Japan
facility: Kobe University Graduate School of Medicine
city: Nara
country: Japan
facility: Nara Medical University Hospital
city: Osaka
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University
city: Rotterdam
country: Netherlands
facility: Thoraxcentre Erasmus MC
city: Madrid
country: Spain
facility: Hospital Univ. Clinico San Carlos
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References:
citation: 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.