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

• Conditions: Fractional Flow Reserve, Myocardial; Coronary Artery Disease

• Registration Number: NCT03237169
• Lead Sponsor: Centro Hospitalar Lisboa Ocidental

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.

Study Timeline

• Study Start: 2016-10-28
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-11
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of Pd/Pamin vs FFR	baseline	Agreement will be tested using the established FFR 0.8 threshold as the binary reference standard.

Secondary Outcome Measures

Name	Time	Method
Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold	baseline	ROC analysis using FFR as reference
Feasibility of Pd/Pamin measurements	Baseline	Description of how often can Pd/Pamin can be measured accurately

Trial Locations

Locations (6)

Institute of Cardiology, Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy

Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta; 🇵🇹 Lisboa, Portugal

Department of Cardiology, University Hospital; 🇫🇷 Lille, France

St. Francis Hospital The Heart Center; 🇺🇸 New York, New York, United States

Hospital Prof. Doutor Fernando da Fonseca; 🇵🇹 Amadora, Portugal

Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz; 🇵🇹 Carnaxide, Portugal