Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience (BEGIN)

Kurashiki Central Hospital

Status: Unknown

Conditions: Coronary Stenosis

Treatments: Device: Bifurcation stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT01574586

BEGIN12

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

2-link stent Nobori

Active Comparator group

Description:

Bifurcation stenting

Treatment:

Device: Bifurcation stenting

3-link stent Xience

Active Comparator group

Description:

Bifurcation stenting

Treatment:

Device: Bifurcation stenting