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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1079 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCI with IVUS guidance

PCI(percutaneous coronary intervention) with IVUS(IntraVascular UltraSound) group

Group Type EXPERIMENTAL

PCI with IVUS guidance

Intervention Type 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.

PCI without IVUS guidance

PCI(percutaneous coronary intervention) group

Group Type ACTIVE_COMPARATOR

PCI without IVUS guidance

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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PCI with IVUS guidance group

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No