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

Study Overview
=================
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

Intervention / Treatment
-----------------
* Procedure: stent technique: Provisional fKBT
* Procedure: stent technique: Routine fKBT


Participation Criteria
=================
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,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Provisional fKBT<br>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<br>* 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<br>|
| Active Comparator: Routine fKBT<br>Stent technique that fKBT was mandatory irrespective of side branch flow after stenting. | Procedure: stent technique: Routine fKBT<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of positive dipyridamole stress technetium scintigraphy |  | 7 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of major cardiac adverse events(MACE) | Including cardiac death,myocardial infarction, stent thrombosis and target vessel revascularization | 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 | 
| Diameter stenosis and late loss in side branch |  | 8 month | 
| Regional summed difference score |  | 7 month |