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Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions.

NCT01238510 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-04-23

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

stent technique: Provisional fKBT

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

PROCEDURE

stent technique: Routine fKBT

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

Sponsors & Collaborators

  • Saiseikai Yokohama City Eastern Hospital

    lead OTHER

Principal Investigators

  • Masahiro Yamawaki, MD,PhD · Saiseikai Yokohama City Eastern Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01238510 on ClinicalTrials.gov