Observational Study of OCT in a Patients Undergoing FFR

Completed

Conditions: Coronary Artery Disease

Interventions: Device: OCT stent guidance

Registration Number: NCT01663896

Lead Sponsor: Abbott Medical Devices

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 418

Inclusion Criteria

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.

Exclusion Criteria

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).
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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting	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))	12 months	Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months

Secondary Outcome Measures

Name	Time	Method
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT	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

Trial Locations

Locations (36): Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Heart Hospital of Austin
🇺🇸
Austin, Texas, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, United States
Centro Cardiologico Monzino
🇮🇹
Milan, Italy
Kobe University Graduate School of Medicine
🇯🇵
Hyogo, Japan
Nara Medical University Hospital
🇯🇵
Nara, Japan
University Hospital Brno
🇨🇿
Brno, Czechia
OLV Hospital
🇧🇪
Aalst, Belgium
Ospedali Riuniti di Bergamo
🇮🇹
Bergamo, Italy
CHC du Marie Lannelongue
🇫🇷
Le Plessis Robinson, France
Scripps Clinic, Green Hospital
🇺🇸
La Jolla, California, United States
The Prince Charles Hospital
🇦🇺
Chermside, Queensland, Australia
Montreal Heart Institute
🇨🇦
Montreal, Quebec, Canada
Wakayama Medical University
🇯🇵
Wakayama, Japan
Gasthuisberg Leuven
🇧🇪
Leuven, Belgium
Deutsches Herzzentrum
🇩🇪
Munich, Germany
Ospedale San Giovanni Addolorata
🇮🇹
Rome, Italy
Loyola University Chicago
🇺🇸
Maywood, Illinois, United States
Rutgers Cardiovascular Institute
🇺🇸
New Brunswick, New Jersey, United States
Dallas VA Medical Center
🇺🇸
Dallas, Texas, United States
University of Texas Medical Branch at Galveston
🇺🇸
Galveston, Texas, United States
CHU Clermont Ferrand
🇫🇷
Clermont-Ferrand, France
Hospital Univ. Clinico San Carlos
🇪🇸
Madrid, Spain
Thoraxcentre Erasmus MC
🇳🇱
Rotterdam, Netherlands
University of Hong Kong
🇨🇳
Hong Kong, Hong Kong, China
Clinique Pasteur
🇫🇷
Toulouse, France
Osaka Saiseikai Nakatsu Hospital
🇯🇵
Osaka, Japan
University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸
Birmingham, Alabama, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
Aurora St. Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
Florida Hospital Orlando
🇺🇸
Orlando, Florida, United States
Baptist Health East
🇺🇸
Louisville, Kentucky, United States
Med. Univ. Vienna
🇦🇹
Vienna, Austria
St. Luke's Hospital/Mid America Heart
🇺🇸
Kansas City, Missouri, United States
Royal Brompton Hospital
🇬🇧
London, United Kingdom