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

This study is currently recruiting participants.

Verified January 2012 by Yonsei University

Sponsor:

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01308281

First received: March 3, 2011

Last updated: January 31, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 3, 2011
Last Updated Date	January 31, 2012
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 3, 2011)	The composite of cardiac death [ Time Frame: 12 months after the index procedure ] [ Designated as safety issue: No ] The composite of cardiac death
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01308281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)
Official Title ^ICMJE	Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Coronary Artery Disease
Intervention ^ICMJE	Procedure: PCI with IVUS guidance 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. Other Name: PCI with IVUS guidance group Procedure: PCI without IVUS guidance 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. Other Name: PCI without IVUS guidance
Study Arm (s)	Experimental: PCI with IVUS guidance PCI(percutaneous coronary intervention) with IVUS(IntraVascular UltraSound) group Intervention: Procedure: PCI with IVUS guidance Active Comparator: PCI without IVUS guidance PCI(percutaneous coronary intervention) group Intervention: Procedure: PCI without IVUS guidance
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	1400
Estimated Completion Date	August 2013
Estimated Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 Lesion 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
Gender	Both
Ages	20 Years to 79 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01308281
Other Study ID Numbers ^ICMJE	1-2010-0025
Has Data Monitoring Committee	Yes
Responsible Party	Yonsei University
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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