Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.

Study Overview
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Brief Summary
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The study is a prospective cohort study conducted in Tianjin Chest Hospital, China. Patients with saphenous vein graft disease after coronary artery bypass graft, and planning for receiving percutaneous coronary intervention after virtual histology intravascular ultrasound will be enrolled between May 2017 and April 2019. These subjects will be followed up at 1, 6 and 12 months post-operation of PCI to assess the short-term and long-term effect.

Official Title
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Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.

Conditions
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Major Adverse Cardiovascular Events, Saphenous Vein Graft Disease, Virtual Histology Intravascular Ultrasound, Percutaneous Coronary Intervention

Intervention / Treatment
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* Diagnostic Test: virtual histology intravascular ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with SVGD after CABG Planning to receive PCI using drug-eluting stents 18 to 80 years old Finishing VH-IVUS examination Willing to participate in the study and sign informed consent Exclusion Criteria: Patients with liver disfunction and renal failure Aspirin and clopidogrel allergy Acute myocardial infarction after CABG History of stroke in the past 3 months Gastrointestinal bleeding and hemoptysis recently Vasculitis and non-atherosclerotic coronary artery disease Coagulation disorders History of malignancy Women during pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCI<br> | Diagnostic Test: virtual histology intravascular ultrasound<br>* Patients with saphenous vein graft disease will be examined using virtual histology intravascular ultrasound, and treated with percutaneous coronary intervention. Then they will be followed up at 1, 6 and 12 months.<br>* Other names: percutaneous coronary intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiovascular events | Cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization are all major adverse cardiovascular events | after PCI for saphenous vein graft disease (SVGD) in one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombolysis In Myocardial Infarction (TIMI) flow in 24 hours after PCI for the SVGD |  | 24 hours after PCI for the SVGD | 
| Number of slow reflow, no reflow or distal embolization of the saphenous vein graft after PCI on the basis of Corrected TIMI Frame Count (TFC) |  | 24 hours after PCI for the SVGD | 
| Success rate of PCI | The residual stenosis of SVG is less than 50% and achieving TIMI flow 3 | 24 hours after PCI for the SVGD |