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

NCT ID: NCT01238510

Last Updated: 2013-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-04-30

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.

Detailed Description

Final kissing balloon technique (FKBT) is effective and accepted technique for the treatment of bifurcation. However, in complex lesion or anatomy, much procedure-time and contrast media are needed to accomplish this technique. Recent FFR study for jailed side branch (SB) demonstrated that angiographic severe stenosis at SB ostium includes "pseudo-stenosis" and stent-deployment jailing SB without FKBT has comparable impact on clinical outcome with FKBT strategy. Considering simple technique for bifurcation, we sought to investigate to compare "provisional FKBT" with "routine FKBT", focusing on actual myocardial ischemia assessed by scintigraphy in 7 month and to examine optimal endpoint of SB ostium.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Provisional fKBT

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

Group Type: ACTIVE_COMPARATOR

stent technique: Provisional fKBT

Intervention Type: PROCEDURE

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

Routine fKBT

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

Group Type: ACTIVE_COMPARATOR

stent technique: Routine fKBT

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

(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,

Exclusion Criteria

(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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saiseikai Yokohama City Eastern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Masahiro Yamawaki

Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masahiro Yamawaki, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Saiseikai Yokohama City Eastern Hospital

Locations

Edogawa Hospital

Tokyo, , Japan

Saiseikai Yokohama City Eastern Hospital

Yokohama, , Japan

Countries

Japan

Other Identifiers

2009009

Identifier Type: -

Identifier Source: org_study_id