Recruiting

Resting Pressure Index vs. Adenosine Hyperemic FFR

Sponsor:

Centro Hospitalar Lisboa Ocidental

Code:

NCT03237169

Conditions

Fractional Flow Reserve, Myocardial

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Fractional Flow Reserve, Myocardial

Coronary Artery Disease

Study ID

NCT03237169

Start date

Oct 28, 2016

Status verified date

May, 2018

Completion date

Sep, 2018

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Prospective cohort

Prospective cohort of patients with stable or stabilized coronary artery disease and de novo coronary lesions, in whom functional evaluation is performed, according do standard clinical indications.

Primary outcome measure

  • Diagnostic accuracy of Pd/Pamin vs FFR [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Locations

St. Francis Hospital The Heart Center

Recruiting

New York, New York, United States, 11576

Contacts

Allen Jeremias, MD

516-390-9640

More Information

Sponsor

Centro Hospitalar Lisboa Ocidental

Last update posted

May 11, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centro Hospitalar Lisboa Ocidental on 2018-05-11.