Clinical trial NCT02002910: Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect
Official title: Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: iFR
FFR
Medical Economy
physiological assessment
SYNTAX score
Lead sponsor: Associations for Establishment of Evidence in Interventions
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 421
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who is adaptable to CAG and/or coronary revascularization

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Medical economy
timeFrame: 1 year after the procedure
measure: Physiological assessment
timeFrame: baseline pocedure
Secondary outcomes:
measure: Incidence of major adverse cardiac and cerebrovascular events(MACCE)
timeFrame: 1year after the pocedure
measure: correlated analysis
timeFrame: baseline pocedure
measure: evaluation of variance
timeFrame: beseline procedure
Other outcomes:
Locations:
city: Minato
country: Japan
facility: NPO Associations for Establishment of Evidence in Interventions
state: Tokyo
Study officials:
name: Masato Nakamura, M.D
role: STUDY_CHAIR
References: