Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR

Status unconfirmed

Conditions studied: Fractional Flow Reserve, Myocardial, Coronary Artery Disease

In brief

To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.

Key facts

Study ID

NCT03237169

Run by

Centro Hospitalar Lisboa Ocidental

People needed

100

Starts

2016-10-28

Expected to finish

2018-09-01

Last updated by the study team

2018-05-11

Who can join

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

You may qualify if…

• Patients undergoing FFR assessment for standard clinical indications, according to individual 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 deemed indicated, in the setting of stable coronary artery disease or non-culprit lesions of non-ST elevation acute coronary syndromes (only in deferred procedures).
• Stenosis deemed amenable for both evaluation with a pressure wire and for potential revascularization.

You may not qualify if…

• Subjects with restenosis in the target vessel.
• Known severe renal insufficiency (examples being but not limited to eGFR <30 ml/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/or revascularization.
• Tandem lesions
• Moderate lesions in patients with multivessel disease in whom at least one lesion in another major epicardic vessel is severe (to minimize lesion interaction), unless the severe 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 interfere with 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 protocol mandated procedures, for example subjects with a prior history heparin induced thrombocytopenia, known intolerance to adenosine or with a contra-indication for dual anti-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 in patients with a recent STEMI undergoing staged procedures.
• Patients with a CTO, regardless of the presence and the extent of angiographic collaterals from the target vessel.

Where it is running

• St. Francis Hospital The Heart Center — New York, New York, United States (enrolling)
• Department of Cardiology, University Hospital — Lille, France (enrolling)
• Institute of Cardiology, Catholic University of the Sacred Heart — Rome, Italy (enrolling)
• Hospital Prof. Doutor Fernando da Fonseca — Amadora, Portugal (enrolling)
• Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz — Carnaxide, Portugal (enrolling)
• Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta — Lisbon, Portugal (enrolling)

Full record on ClinicalTrials.gov

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