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

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

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.

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.

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