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

Last updated: May 9, 2018
Sponsor: Centro Hospitalar Lisboa Ocidental
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Myocardial Ischemia

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT03237169
2017-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients undergoing FFR assessment for standard clinical indications, according toindividual 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 deemedindicated, in the setting of stable coronary artery disease or non-culprit lesions ofnon-ST elevation acute coronary syndromes (only in deferred procedures).

  7. Stenosis deemed amenable for both evaluation with a pressure wire and for potentialrevascularization.

Exclusion

Exclusion Criteria:

  1. Subjects with restenosis in the target vessel.

  2. Known severe renal insufficiency (examples being but not limited to eGFR <30ml/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/orrevascularization.

  5. Tandem lesions

  6. Moderate lesions in patients with multivessel disease in whom at least one lesion inanother major epicardic vessel is severe (to minimize lesion interaction), unless thesevere 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 interferewith 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 protocolmandated procedures, for example subjects with a prior history heparin inducedthrombocytopenia, known intolerance to adenosine or with a contra-indication for dualanti-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 inpatients with a recent STEMI undergoing staged procedures.

  19. Patients with a CTO, regardless of the presence and the extent of angiographiccollaterals from the target vessel.

Study Design

Total Participants: 100
Study Start date:
October 28, 2016
Estimated Completion Date:
September 30, 2018

Study 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.

Connect with a study center

  • Department of Cardiology, University Hospital

    Lille,
    France

    Active - Recruiting

  • Institute of Cardiology, Catholic University of the Sacred Heart

    Rome,
    Italy

    Active - Recruiting

  • Hospital Prof. Doutor Fernando da Fonseca

    Amadora, 2720-276
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz

    Carnaxide, 2790-134
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta

    Lisboa,
    Portugal

    Active - Recruiting

  • St. Francis Hospital The Heart Center

    New York, New York 11576
    United States

    Active - Recruiting

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