Diffuse/tandem Coronary Lesions
Conditions
Interventions
Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve
Sponsors
Matsuo Hitoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.>20 years of age 2.Willing to participate and able to understand, read, and sign the informed consent document before the planned procedure 3.Eligible for coronary angiography and/or percutaneous coronary intervention 4.Patient with at least 2 separate (>10mm apart) or diffuse (>20mm) de novo angiographically 50-90% stenoses in one native major epicardial vessel or their major branches (The stenosis will be regarded as single when the gap is 10mm or shorter between the 2 narrowings) 5.Single coronary artery disease 6.Stable coronary artery disease (with or without a history of PCI)
Exclusion criteria
Exclusion criteria: 1.Previous CABG with patent grafts to the interrogated vessel 2.Total coronary occlusions 3.Cardiogenic shock, or intra-aortic balloon pumping 4.Contraindications to PCI or drug-eluting stent (DES) implantation 5.Malignant disease with unfavorable prognosis that may influence survival within the next 3 years 6.EF 200kg 16.Severe allergy to contrast media 17.Contraindications to antithrombotic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of residual myocardial ischemia in patients who undergo iFR/FFR interrogation to guide revascularization at 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Major adverse cardiac events (MACE) rate in the iFR and FFR groups at 2 months and 1 year (key secondary endpoint) 2.All-cause death at 2 months and 1 year 3.Cardiovascular death at 2 months and 1 year 4.Nonfatal myocardial infarction at 2 months and 1 year 5.Unplanned revascularization by PCI or coronary artery bypass surgery (CABG) at 2 months and 1 year 6.MACE rate in LAD and non-LAD at 2 months and 1 year 7.MACE rate in patients with diabetes mellitus at 2 months and 1 year 8.Costs associated to iFR or FFR guidance 9.Canadian Cardiovascular Society grading of angina pectoris in patients included in the iFR or FFR guidance groups 10.Summed stress and difference score at 2 months in the iFR or FFR guidance groups 11.Summed stress and difference score in patients with diabetes mellitus at 2 months in the iFR or FFR guidance groups 12.Procedural time 13.The number of stents 14.Total stent lengths 15.MACE according to lipid profile 16.MACE according to renal function 17.the association between QCA by core lab and pressure pullback gradient at each stenosis 18.conparison of QCA results by SyncVision at the sites and QCA results by core lab 19.Comparison of stenosis length by SyncVision and stent length | — |
Contacts
Public ContactYoshiaki Kawase
Gifu Heart Center
Outcome results
None listed