Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Yonsei University
- Enrollment
- 1079
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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
Time Frame: 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