INTEGRAL study

JRCT ID: jRCTs072200027

Registered date:24/08/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Diffuse/tandem Coronary Lesions
• Date of first enrollment: 02/10/2020
• Target sample size: 300
• Study type: Interventional
• Intervention(s): Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve

Outcome(s)

• Primary Outcome: Prevalence of residual myocardial ischemia in patients who undergo iFR/FFR interrogation to guide revascularization at 2 months

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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 < 30%
7.eGFR < 15mL/min/1.73m2
8.Pregnant or planning to be pregnant
9.Frequent arrhythmia
10.Acute coronary syndrome or a history of myocardial infarction
11.Severe valvular heart disease
12.Distal coronary disease < 2.5 mm by visual estimation
13.Baseline flow < TIMI 3 or intracoronary thrombus
14.Included in other intervention trials
15.Weight > 200kg
16.Severe allergy to contrast media
17.Contraindications to antithrombotic therapy

Related Information

• Primary Sponsor: Matsuo Hitoshi
• Source(s) of Monetary Support: Philips Japan, Ltd.