Observational Study of OCT in a Patients Undergoing FFR

Coronary Artery Disease Clinical Trial

— ILUMIEN I  

Official title:

Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663896
• Other study ID #: SJM-CVD-0612
• Status: Completed
• Start date: December 11, 2012
• Est. completion date: October 2015

Study information

• Verified date: June 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: October 2015
• Est. primary completion date: March 12, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• OCT stent guidance
Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  Czechia,  France,  Germany,  Italy,  Japan,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	In-hospital until discharge
Primary	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	30 Days
Primary	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	12 months
Secondary	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	1 Year