Status:
UNKNOWN
Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR
Lead Sponsor:
Centro Hospitalar Lisboa Ocidental
Collaborating Sponsors:
Abbott Medical Devices
Cardiovascular Research Foundation, New York
Conditions:
Fractional Flow Reserve, Myocardial
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 ev...
Detailed Description
Coronary lesions with a potential indication for percutaneous coronary intervention or warranting invasive physiological interrogation (in the opinion of the investigator) will undergo PressureWire™ a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 28 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03237169
Start Date
October 28 2016
End Date
September 1 2018
Last Update
May 11 2018
Active Locations (6)
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1
St. Francis Hospital The Heart Center
New York, New York, United States, 11576
2
Department of Cardiology, University Hospital
Lille, France
3
Institute of Cardiology, Catholic University of the Sacred Heart
Rome, Italy
4
Hospital Prof. Doutor Fernando da Fonseca
Amadora, Portugal, 2720-276