NCT01238510

Brief Summary

In the setting of single stent strategy for treatment of bifurcation, we investigate to compare simple strategy as "provisional final kissing balloon technique(fKBT)" to complex one as "routine FKBT", focusing on actual myocardial ischemia assessed by scintigraphy in 7-month and to examine optimal endpoint of side branch ostium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Mar 2010

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

3.1 years

First QC Date

November 9, 2010

Last Update Submit

April 22, 2013

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of positive dipyridamole stress technetium scintigraphy

    7 month

Secondary Outcomes (7)

  • Composite of major cardiac adverse events(MACE)

    8 month

  • Angiographic restenosis rate in main vessel

    8 month

  • Fluoroscopic time

    after procedure

  • Amount of contrast media

    after procedure

  • Number of stent and wire use

    after procedure

  • +2 more secondary outcomes

Study Arms (2)

Provisional fKBT

ACTIVE COMPARATOR

Stent technique that final kissing balloon technique(fKBT) is performed if side branch flow was aggravated to TIMI0-2 after stent deployment

Procedure: stent technique: Provisional fKBT

Routine fKBT

ACTIVE COMPARATOR

Stent technique that fKBT was mandatory irrespective of side branch flow after stenting.

Procedure: stent technique: Routine fKBT

Interventions

stent technique: Provisional fKBTPROCEDURE

Provisional use of fKBT only when SB flow is aggravated to TIMI0-2 after stenting for non-left main bifurcation. Additional stenting for SB is recommended if residual stenosis (\>50% in visual) or TIMI flow grade (\<TIMI 3) was seen at SB after fKBT. Stent type: Everolimus-eluting stent only

Provisional fKBT
stent technique: Routine fKBTPROCEDURE

Mandatory use of fKBT irrespective of SB flow after stenting for non-left main bifurcation. Additional stenting for SB is recommended if residual stenosis (\>50% in visual) or TIMI flow grade (\<TIMI 3) was seen at SB after fKBT. Stent type: Everolimus-eluting stent only

Routine fKBT

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (Patient) Patient who has angina or documented ischemia, Patients who are eligible for drug eluting stent, Age \>=18, Patient who received informed consent, Patient who can receive dipyridamole-stress-technetium scintigraphy.
  • (Lesion) Non-left main bifurcation except for Medina class (0,0,1), De-Novo lesion, Vessel diameter in visual (main vessel\>2.5mm, side branch \>2.0mm), SB lesion length \<5mm in visual estimate, MB lesion length \< 46mm in visual, TIMI 3 in main vessel as well as side branch,

You may not qualify if:

  • (Patient) Patients who is pregnant, Patient contraindicated for antiplatelet therapy, Patients whose ejection fraction is less than 30%, Patients who has renal dysfunction, creatinine \>=2.3, Patients who has live dysfunction, Patients who cannot agree with informed consent, Patient whose life expectancy is less than 1 year, Patients contraindicated for dipyridamole-stress-technetium scintigraphy.
  • (Lesion) Target site of acute myocardial infarction, Left main disease, In-Stent restenosis lesion, Bypass graft, Chronic total occlusion, Main vessel reference diameter \>4.5mm, Bifurcation lesion that needs intended 2 stent strategy, Highly tortus and calcified lesion,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Edogawa Hospital

Tokyo, Japan

Location

Saiseikai Yokohama City Eastern Hospital

Yokohama, 230-8765, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Masahiro Yamawaki, MD,PhD

    Saiseikai Yokohama City Eastern Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 10, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

JP(2)