Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience

Not Applicable

• Conditions: Coronary Stenosis
• Interventions: Device: Bifurcation stenting

• Registration Number: NCT01574586
• Lead Sponsor: Kurashiki Central Hospital

Brief Summary

The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions.

The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-06
• Study First Posted: 2012-04-10
• Primary Completion: 2014-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Patient eligible for percutaneous coronary intervention
2. Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
3. De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%)
4. Second vessel at coronary bifurcation treatable with trial device during the procedure
5. True coronary bifurcation, ≥50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1,
6. Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch
7. Target lesion treatable with one or two stents in both the main and side branches
8. Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery
9. Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches

Exclusion Criteria

A. General restrictions

1. Unable to be followed by the implementing medial institution
2. Life expectancy <1 year
3. Acute myocardial infarction (<1 week)
4. Left ventricular ejection fraction <30%
5. Scheduled for elective treatment requiring antiplatelet drug Withdrawal
6. Deemed as unsuitable by the investigator or subinvestigator
7. Serum creatinine level ≥2.0 Mg/dl

B. Vascular morphological restrictions

1. Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting
2. In-stent restenosis
3. Severe calcification

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3-link stent Xience	Bifurcation stenting	Bifurcation stenting
2-link stent Nobori	Bifurcation stenting	Bifurcation stenting

Primary Outcome Measures

Name	Time	Method
Minimum lumen diameter of the side branch ostium in bifurcation	8 months

Secondary Outcome Measures

Name	Time	Method
Incidence of MACE	in-hospital, 30 days, 8 months, 1 year

Trial Locations

Locations (1)

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Japan