Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)

Study Overview
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Brief Summary
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This study is designed as a prospective, randomized, multi-center trial to demonstrate an inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting stents(EES) at long lesions(> 28 mm) in clinical outcomes at 12 months as a primary objective and safety of 6- month dual antiplatelet therapy following EES implantation in comparison with a 12-month dual antiplatelet therapy.

Detailed Description
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The primary purpose of this study is to investigate the impact of IVUS guidance on the clinical outcomes after implantation of DES at long lesions > 28 mm.

Official Title
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Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: PCI with IVUS guidance
* Procedure: PCI without IVUS guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 years old or older Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia Non-emergent conditions Patients with signed informed consent Stent length ≥28 mm by angiography estimation Significant coronary artery stenosis (> 50% by visual estimate) considered for coronary revascularization with stent implantation Reference vessel diameter of 2.5 to 4.0 mm by operator assessment Exclusion Criteria: Acute ST elevation myocardial infarction within 48 hours Contraindication to anti-platelet agents & bleeding history within prior 3 months Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus or other -limus group Prior history of the following presentations Cerebral vascular accident (not including transient ischemic attack) Peripheral artery occlusive diseases Thromboembolic disease Stent thrombosis Age > 80 years old Severe hepatic dysfunction (3 times normal reference values) Significant renal dysfunction (Serum creatinine > 2.0 mg/dl) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis Cardiogenic shock LVEF < 40% Pregnant women or women with potential childbearing Life expectancy < 1 year Left main disease requiring PCI Bifurcation lesion with 2-stent technique Chronic total occlusion Presence of previously implanted DES within 6-month In-stent restenosis lesion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCI with IVUS guidance<br>PCI(percutaneous coronary intervention) with IVUS(IntraVascular UltraSound) group | Procedure: PCI with IVUS guidance<br>* Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.<br>* Other names: PCI with IVUS guidance group;|
| Active Comparator: PCI without IVUS guidance<br>PCI(percutaneous coronary intervention) group | Procedure: PCI without IVUS guidance<br>* Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance | Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance | 12 months after the index procedure |