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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01308281
First received: March 3, 2011
Last updated: July 13, 2014
Last verified: March 2014

March 3, 2011
July 13, 2014
October 2010
November 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
The composite of cardiac death [ Time Frame: 12 months after the index procedure ] [ Designated as safety issue: No ]
The composite of cardiac death
Complete list of historical versions of study NCT01308281 on ClinicalTrials.gov Archive Site
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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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • 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
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1400
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 79 Years
No
Korea, Republic of
 
NCT01308281
1-2010-0025
Yes
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP