Overview

This trial is active, not recruiting.

Condition coronary stenosis
Treatment bifurcation stenting
Sponsor Kurashiki Central Hospital
Start date April 2012
End date May 2014
Trial size 240 participants
Trial identifier NCT01574586, BEGIN12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Bifurcation stenting
bifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience
(Active Comparator)
Bifurcation stenting
bifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience

Primary Outcomes

Measure
Minimum lumen diameter of the side branch ostium in bifurcation
time frame: 8 months

Secondary Outcomes

Measure
Incidence of MACE
time frame: in-hospital, 30 days, 8 months, 1 year

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Kurashiki Central Hospital.