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

NCT02002910 | Completed DMC

• 1 other identifier: J-DEFINE
• Study Type: observational
• Target: 421
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

iFR; FFR; Medical Economy; physiological assessment; SYNTAX score

Outcome Measures

Primary Outcomes (2)

• Medical economy

  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

  Alteration in treatment protocol. Change in SYNTAX score.

  baseline pocedure

Secondary Outcomes (3)

• Incidence of major adverse cardiac and cerebrovascular events(MACCE)

  1year after the pocedure

• correlated analysis

  baseline pocedure

• evaluation of variance

  beseline procedure

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who is adaptable to CAG and/or coronary revascularization

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Associations for Establishment of Evidence in Interventions: lead

Study Sites (1)

NPO Associations for Establishment of Evidence in Interventions

Minato, Tokyo, 105-0013, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Masato Nakamura, M.D

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: December 6, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: September 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

JP (1)