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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308281
• Other study ID #: 1-2010-0025
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: July 25, 2016
• Start date: October 2010
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1079
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 months after the index procedure	No