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

NCT01574586 | Unknown

• 1 other identifier: BEGIN12
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Stenosis

Keywords

True Bifurcation stenosis

Outcome Measures

Primary Outcomes (1)

• Minimum lumen diameter of the side branch ostium in bifurcation

  8 months

Secondary Outcomes (1)

• Incidence of MACE

  in-hospital, 30 days, 8 months, 1 year

Study Arms (2)

2-link stent Nobori

ACTIVE COMPARATOR

Bifurcation stenting

Device: Bifurcation stenting

3-link stent Xience

ACTIVE COMPARATOR

Bifurcation stenting

Device: Bifurcation stenting

Interventions

Bifurcation stenting DEVICE

Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience

2-link stent Nobori; 3-link stent Xience

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• A. General restrictions
• Unable to be followed by the implementing medial institution
• Life expectancy \<1 year
• Acute myocardial infarction (\<1 week)
• Left ventricular ejection fraction \<30%
• Scheduled for elective treatment requiring antiplatelet drug Withdrawal
• Deemed as unsuitable by the investigator or subinvestigator
• Serum creatinine level ≥2.0 Mg/dl
• B. Vascular morphological restrictions
• Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting
• In-stent restenosis
• Severe calcification

Sponsors & Collaborators

• Kurashiki Central Hospital: lead

Study Sites (1)

Kurashiki Central Hospital

Kurashiki, 710-8602, Japan

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 10, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2015
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

JP (1)