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

Coronary Stenosis Clinical Trial

— BEGIN  

Official title:

A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01574586
• Other study ID #: BEGIN12
• Status: Active, not recruiting
• Phase: N/A
• First received: April 6, 2012
• Last updated: April 6, 2015
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: Kurashiki Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: June 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Device:
• Bifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience

Locations

Country	Name	City	State
Japan	Kurashiki Central Hospital	Kurashiki

Sponsors (1)

Lead Sponsor	Collaborator
Kurashiki Central Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum lumen diameter of the side branch ostium in bifurcation		8 months	No
Secondary	Incidence of MACE		in-hospital, 30 days, 8 months, 1 year	Yes