Observational Study of OCT in a Patients Undergoing FFR

NCT ID: NCT01663896

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 418 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-11
• Study Completion Date: 2015-10-31

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Single or multi vessel disease

Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants.

OCT stent guidance

Intervention Type: DEVICE

Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT

Interventions

OCT stent guidance

Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Scripps Clinic, Green Hospital

La Jolla, California, United States

Florida Hospital Orlando

Orlando, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Loyola University Chicago

Maywood, Illinois, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Baptist Health East

Louisville, Kentucky, United States

St. Luke's Hospital/Mid America Heart

Kansas City, Missouri, United States

Rutgers Cardiovascular Institute

New Brunswick, New Jersey, United States

Mount Sinai Medical Center

New York, New York, United States

Heart Hospital of Austin

Austin, Texas, United States

Dallas VA Medical Center

Dallas, Texas, United States

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

The Prince Charles Hospital

Chermside, Queensland, Australia

Med. Univ. Vienna

Vienna, , Austria

OLV Hospital

Aalst, , Belgium

Gasthuisberg Leuven

Leuven, , Belgium

Montreal Heart Institute

Montreal, Quebec, Canada

University of Hong Kong

Hong Kong, Hong Kong, China

University Hospital Brno

Brno, , Czechia

CHU Clermont Ferrand

Clermont-Ferrand, , France

CHC du Marie Lannelongue

Le Plessis-Robinson, , France

Clinique Pasteur

Toulouse, , France

Deutsches Herzzentrum

Munich, , Germany

Ospedali Riuniti di Bergamo

Bergamo, , Italy

Centro Cardiologico Monzino

Milan, , Italy

Ospedale San Giovanni Addolorata

Rome, , Italy

Kobe University Graduate School of Medicine

Hyōgo, , Japan

Nara Medical University Hospital

Nara, , Japan

Osaka Saiseikai Nakatsu Hospital

Osaka, , Japan

Wakayama Medical University

Wakayama, , Japan

Thoraxcentre Erasmus MC

Rotterdam, , Netherlands

Hospital Univ. Clinico San Carlos

Madrid, , Spain

Royal Brompton Hospital

London, , United Kingdom

Countries

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

References

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.

Reference Type: DERIVED

PMID: 26242713 (View on PubMed)

Other Identifiers

SJM-CVD-0612

Identifier Type: -

Identifier Source: org_study_id