Clinical trial NCT03237169: Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR
Official title: Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fractional Flow Reserve, Myocardial
Coronary Artery Disease
Lead sponsor: Centro Hospitalar Lisboa Ocidental
Sponsor class: OTHER_GOV
Collaborators: name: Abbott Medical Devices
name: Cardiovascular Research Foundation, New York
First posted: 2017-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive subjects scheduled for coronary angiography or PCI in whom operator decides to perform FFR will be approached for enrollment. Being a first-in-man study of a novel pressure index intended for future validation and use in a clinical setting, a full assessment of its range throughout the entire spectrum of lesion severity is warranted. As such, the protocol will allow for the inclusion of both less severe as well as of critical (\>90%) lesions. Patients with either single or multiple vessel disease will be included.

Data on additional lesions may or may not be collected but will not be used in the study. Vessels with sequential stenosis and tandem lesions will be evaluated and treated according to routine clinical practice, but not included in the study data collected.

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 evaluation is warranted.

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™ assessment under 2 conditions: rest and adenosine hyperemia. The measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest repeatability. Subsequent treatment decisions will be made by the operator according to the standard practice based on the adenosine FFR value together with all other clinical information.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing FFR assessment for standard clinical indications, according to individual operator decision.
2. Age ≥ 18 years.
3. Provided signed written informed consent for data collection the collection.
4. De novo coronary artery disease in target vessel.
5. Single or multiple vessel disease.
6. 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).
7. Stenosis deemed amenable for both evaluation with a pressure wire and for potential revascularization.

Exclusion Criteria:

1. Subjects with restenosis in the target vessel.
2. Known severe renal insufficiency (examples being but not limited to eGFR \<30 ml/kg/min, serum creatinine ≥ 2.5 mg/dL or on dialysis).
3. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
4. Vessel(s) and lesion(s) not amenable for evaluation with a PressureWire™ and/or revascularization.
5. Tandem lesions
6. 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).
7. Left ventricular ejection fraction \<50%
8. Known severe left ventricular hypertrophy
9. Atrial fibrillation or any other significant arrhythmia (including an heart rate \<50/min on sinus rhythm)
10. Systolic blood pressure \<90 mmHg.
11. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results
12. Currently participating in another clinical study that interferes with study results.
13. Pregnant or nursing females
14. Planned or prior heart transplantation or listed for heart transplant.
15. 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.
16. Patients with severe valvular disease
17. Patients with severe pulmonary disease
18. Culprit lesions in ACS patients are not to be included nor non-culprit lesions in patients with a recent STEMI undergoing staged procedures.
19. Patients with a CTO, regardless of the presence and the extent of angiographic collaterals from the target vessel.

Primary outcomes:
measure: Diagnostic accuracy of Pd/Pamin vs FFR
timeFrame: baseline
Secondary outcomes:
measure: Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold
timeFrame: baseline
measure: Feasibility of Pd/Pamin measurements
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Francis Hospital The Heart Center
state: New York
city: Lille
country: France
facility: Department of Cardiology, University Hospital
city: Rome
country: Italy
facility: Institute of Cardiology, Catholic University of the Sacred Heart
city: Amadora
country: Portugal
facility: Hospital Prof. Doutor Fernando da Fonseca
city: Carnaxide
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta
Study officials:
affiliation: Centro Hospitalar de Lisboa Ocidental
name: Luis Raposo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Fernando da Fonseca
name: Sergio Bravo Baptista, MD, PhD
role: STUDY_CHAIR
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