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Status unknownNCT01574586BEGINUpdated Apr 7, 2015

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

An interventional study of Bifurcation stenting in Coronary Stenosis, sponsored by Kurashiki Central Hospital. Status unknown at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by Kurashiki Central Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Stenosis

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Keywords

  • True Bifurcation stenosis
03

In context

Coronary Stenosis

302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.

This study's planned enrollment of 240 is above the median of 200 across 160 interventional studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

Kurashiki Central Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Active comparator
    2-link stent Nobori

    Bifurcation stenting

    Device: Bifurcation stenting

  • Active comparator
    3-link stent Xience

    Bifurcation stenting

    Device: Bifurcation stenting

Interventions

  • DeviceBifurcation stenting

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

06

What researchers measure

Primary outcomes

  1. Minimum lumen diameter of the side branch ostium in bifurcation

    Time frame: 8 months

Secondary outcomes

  1. Incidence of MACE

    Time frame: in-hospital, 30 days, 8 months, 1 year

07

Study locations

1 site
  • Kurashiki Central Hospital
    Kurashiki, 710-8602, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01574586
Lead sponsor
Kurashiki Central Hospital
Responsible party
Sponsor
First posted
Apr 10, 2012
Start date
Apr 2012
Primary completion
May 2014
Completion
Jun 2015 (estimated)
Last update
Apr 7, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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