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

Yonsei University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: PCI without IVUS guidance; Procedure: PCI with IVUS guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT01308281

1-2010-0025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,079 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,079 participants in 2 patient groups

PCI with IVUS guidance

Experimental group

Description:

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

Treatment:

Procedure: PCI with IVUS guidance

PCI without IVUS guidance

Active Comparator group

Description:

PCI(percutaneous coronary intervention) group

Treatment:

Procedure: PCI without IVUS guidance