Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch

Study Overview
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Brief Summary
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Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.

Detailed Description
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Among the bifurcation type, bifurcation lesion without significant side branch stenosis (<50%) usually did not require side branch stenting, but owing to several putative mechanism including dissection, thrombosis formation, embolization of plaque debris, ostial compromise by displaced stent strut, and snow plow effect, the side branch might be compromised. In this situation, the strategy to achieve optimal results has not been reported. Recently, FFR study showed that most jailed side branch (vessel size >2.0 mm. DS>50%) after main branch stenting did not have functional significance. We compared strategies with or without routine kissing balloon dilatation for less than 50% stenosis after simple DES crossing for bifurcation lesions (bifurcation type 1.1.0, 1.0.0, and 0.1.0 according to Medina classification) with serial change of FFR measurement.

Official Title
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Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: kissing balloon
* Procedure: without kissing balloon angioplasty leave alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Patients with angina and documented ischemia or patients with documented silent ischemia Patients who are eligible for intracoronary stenting Age >18 years, <75 ages Angiographic De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0 Main vessel : >= 2.5 mm in vessel size, >= 50% in diameter stenosis and =< 50 mm in lesion length by visual estimation, in which the lesion is covered with =< 2 stents Side branch :>= 2.0 mm in vessel size and < 50% diameter stenosis by visual estimation Exclusion Criteria: History of bleeding diathesis or coagulopathy Pregnant Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus, paclitaxel and zotarolimus Limited life-expectancy (less than 1 year) due to combined serious disease ST-elevation acute myocardial infarction =< 2 weeks Characteristics of lesion: Left main disease In-stent restenosis Graft vessels TIMI flow =< grade 2 in the side branch Chronic total occlusion Renal dysfunction, creatinine >= 2.0mg/dL Contraindication to aspirin, clopidogrel or cilostazol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bifurcation stent techniqe<br>cross over stenting without kissing balloon angioplasty leave alone | Procedure: without kissing balloon angioplasty leave alone<br>* simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions<br>* Other names: sirolimus, zotarolimus, paclitaxel, and everolimus stents;|
| Experimental: bifurcation stent technique<br>kissing balloon angioplasty | Procedure: kissing balloon<br>* simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions<br>* Other names: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy | 8 month after PCI | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of side branch jail after main vessel stenting according to the stent type used | Day 1 (24 hours after the index procedure) | Day 1 | 
| Angiographic reocclusion rate of side branch | 8month after PCI | 8 months | 
| Angiographic restenosis rate of side branch and the main vessel | 8month after PCI | 8 months | 
| Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure | 8month after PCI | 8 months | 
| Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type | 8month after PCI | 8 months | 
| Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type | 8month after PCI | 8 months | 
| Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization |  | 2 years | 
| FFR of the side branch at post-procedure and at follow-up | Day 1 (immediately after the index procedure)and 8month after PCI | Day 1, 8 months | 
| Incidence of peri-procedural cardiac enzyme elevation | Day 1 (24 hours after the index procedure) | Day 1 | 
| Fluoroscopic time | Day 1 (immediately after the index procedure) | Day 1 | 
| Procedure time | Day 1 (immediately after the index procedure) | Day 1 | 
| Amount of contrast agent | Day 1 (immediately after the index procedure) | Day 1 | 
| Number of used stents | Day 1 (immediately after the index procedure) | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, bifurcation, balloon angioplasty