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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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Procedure: PCI with IVUS guidance
Procedure: PCI without IVUS guidance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The composite of cardiac death [ Time Frame: 12 months after the index procedure ] [ Designated as safety issue: No ]
    The composite of cardiac death


Estimated Enrollment: 1400
Study Start Date: October 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI with IVUS guidance
PCI(percutaneous coronary intervention) with IVUS(IntraVascular UltraSound) group
 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
Active Comparator: PCI without IVUS guidance
PCI(percutaneous coronary intervention) 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308281

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Myeong-Ki Hong, MD, Ph.D     82-2-2228-8460     mkhong61@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01308281     History of Changes
Other Study ID Numbers: 1-2010-0025
Study First Received: March 3, 2011
Last Updated: January 31, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013