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Completed

NCT Number: NCT02002910

Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect

To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide change and to analyze the cost-effectiveness of its dual diagnosis.

To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NPO Associations for Establishment of Evidence in Interventions

Minato, Tokyo, 105-0013, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>=20 years old.
  • Patient who can understand informed consent of the clinical study and signed the consent.
  • Patient who is adaptable to CAG and/or coronary revascularization
  • Patient who has evaluated stenotic lesion (stenosis>50% in visual judgment) by CAG at main epicardial vessel and its branch or who suspected to have it.

Exclusion criteria

  • Patient with known contraindications to Adenosine Triphosphate(ATP) and/or papaverine hydrochloride
  • Target vessel diameter<=2.0mm
  • Lesion with Chronic Total Occlusion(CTO) (registration allowed if other branch has stenosis more than 50% in visual judgment)
  • Patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block.
  • Acute Myocardial Infarction(AMI) patient
  • Patient who is disqualified for FFR and coronary revascularization by the investigator.
  • Lesion is disqualified for Percutaneous Coronary Intervention(PCI) by the investigator.
  • Patient who has critical valvular disease of heart. (moderate or severe Aortic valve stenosis(AS)/Aortic Regurgitation(AR)/Mitral Stenosis(MS)/Mitral Regurgitation(MR))
  • Patient with a prior Coronary Artery Bypass Graft(CABG) on target vessel.
  • Patient with severe renal dysfunction. (serum creatinine>=2.0mg/dl)
  • Patient on hemodialysis.
  • Body weight>=200kg
  • Patient who needs ventricular assist device to ensure hemodynamic stability (heart rate<50/min, SBP<90mmHg)
  • Patient who expects to live less than 2 years at the registration
  • Patient with contraindications to an antithrombotic therapy or an anticoagulant therapy.
  • Patient who is poor compliance with drug treatment.
  • Patient who is allergic to contrast agent.
  • Left Ventricular Ejection Fraction(LVEF)>=30%
  • Patient who has the history of PCI with Drug-Eluting Stent(DES) in recent 3 months before registration.
  • Patient who has the history of PCI with Bare Metal Stent(BMS) or Plain Old Balloon Atherectomy(POBA) in recent 1 year before registration.
  • Patient who has possibility of pregnancy, under breast-feeding and positive pregnancy test in 14days prior to the PCI.
  • Patients with inadequacy to join this clinical study.
  • Patient who has been enrolled any other clinical study.

Treatment and study plan

Primary outcomes

  1. Medical economy

    Time frame: 1 year after the procedure

    To evaluate the healthcare cost-effectiveness in QALY(Quality Adjusted Life Year)converted by Japanese functional score ; Quality of Life(QOL) questionnaire (EQ-5D) and the cost postulated by CAG strategy with its iFR/FFR hybrid strategy.

    To collect the healthcare cost related MACCE at the timing of 6 and 12 months FU point. (Included emergency visit) To collect QOL questionnaire (EQ-5D) at the timing of just after the treatment and 12 months follow up point.

  2. Physiological assessment

    Time frame: baseline pocedure

    Alteration in treatment protocol. Change in SYNTAX score.

Secondary outcomes

  1. Incidence of major adverse cardiac and cerebrovascular events(MACCE)

    Time frame: 1year after the pocedure

    MACCE include all-cause death, cerebrovascular accident(CVA), myocardial infarction(MI), and repeat revascularization.

  2. correlated analysis

    Time frame: baseline pocedure

    Area under receiver-operating characteristic curve(ROC) Classification agreement between iFR and FFR in this registry, Demonstrated using the area under the receiver-operating characteristic curve(FFR cut-off 0.8 or 0.75).

  3. evaluation of variance

    Time frame: beseline procedure

    Treatment categorization disagreements of iFR and FFR are analyzed by multi-variable analysis processing to calculate Characteristic factors.

Sponsors and collaborators

Lead sponsor

Associations for Establishment of Evidence in Interventions

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 6, 2013
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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