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Completed

NCT Number: NCT01308281

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCI with IVUS guidance

Procedure

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 names: PCI with IVUS guidance group

PCI without IVUS guidance

Procedure

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2011
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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