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

January 26, 2017 updated by: Associations for Establishment of Evidence in Interventions

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
421

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Minato, Tokyo, Japan, 105-0013
        • NPO Associations for Establishment of Evidence in Interventions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient who is adaptable to CAG and/or coronary revascularization

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year after the procedure
Physiological assessment
Time Frame: baseline pocedure
Alteration in treatment protocol. Change in SYNTAX score.
baseline pocedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1year after the pocedure
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).
baseline pocedure
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.
beseline procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Associations for Establishment of Evidence in Interventions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • J-DEFINE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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