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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: PCI without IVUS guidance; Procedure: PCI with IVUS guidance

• Registration Number: NCT01308281
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1079

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI without IVUS guidance	PCI without IVUS guidance	PCI(percutaneous coronary intervention) group
PCI with IVUS guidance	PCI with IVUS guidance	PCI(percutaneous coronary intervention) with IVUS(IntraVascular UltraSound) group

Primary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of