Phase
Condition
Chest Pain
Myocardial Ischemia
Hypercholesterolemia
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients undergoing FFR assessment for standard clinical indications, according toindividual operator decision.
Age ≥ 18 years.
Provided signed written informed consent for data collection the collection.
De novo coronary artery disease in target vessel.
Single or multiple vessel disease.
Patient eligible for elective or ad hoc PCI (or CABG), if revascularization is deemedindicated, in the setting of stable coronary artery disease or non-culprit lesions ofnon-ST elevation acute coronary syndromes (only in deferred procedures).
Stenosis deemed amenable for both evaluation with a pressure wire and for potentialrevascularization.
Exclusion
Exclusion Criteria:
Subjects with restenosis in the target vessel.
Known severe renal insufficiency (examples being but not limited to eGFR <30ml/kg/min, serum creatinine ≥ 2.5 mg/dL or on dialysis).
Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
Vessel(s) and lesion(s) not amenable for evaluation with a PressureWire™ and/orrevascularization.
Tandem lesions
Moderate lesions in patients with multivessel disease in whom at least one lesion inanother major epicardic vessel is severe (to minimize lesion interaction), unless thesevere lesion is treated first (see above).
Left ventricular ejection fraction <50%
Known severe left ventricular hypertrophy
Atrial fibrillation or any other significant arrhythmia (including an heart rate <50/min on sinus rhythm)
Systolic blood pressure <90 mmHg.
Any other medical condition that in the opinion of the investigator will interferewith patient safety or study results
Currently participating in another clinical study that interferes with study results.
Pregnant or nursing females
Planned or prior heart transplantation or listed for heart transplant.
Any condition that precludes the subject from undergoing PCI or any of the protocolmandated procedures, for example subjects with a prior history heparin inducedthrombocytopenia, known intolerance to adenosine or with a contra-indication for dualanti-platelet therapy.
Patients with severe valvular disease
Patients with severe pulmonary disease
Culprit lesions in ACS patients are not to be included nor non-culprit lesions inpatients with a recent STEMI undergoing staged procedures.
Patients with a CTO, regardless of the presence and the extent of angiographiccollaterals from the target vessel.
Study Design
Study Description
Connect with a study center
Department of Cardiology, University Hospital
Lille,
FranceActive - Recruiting
Institute of Cardiology, Catholic University of the Sacred Heart
Rome,
ItalyActive - Recruiting
Hospital Prof. Doutor Fernando da Fonseca
Amadora, 2720-276
PortugalActive - Recruiting
Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz
Carnaxide, 2790-134
PortugalActive - Recruiting
Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta
Lisboa,
PortugalActive - Recruiting
St. Francis Hospital The Heart Center
New York, New York 11576
United StatesActive - Recruiting
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