Observational Study of OCT in a Patients Undergoing FFR

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01663896

Run by

Abbott Medical Devices

People needed

418

Starts

2012-12-11

Expected to finish

2015-10-01

Last updated by the study team

2020-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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