Status:
COMPLETED
Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions.
Lead Sponsor:
Saiseikai Yokohama City Eastern Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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",...
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...
Eligibility Criteria
Inclusion
- (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
- (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,
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01238510
Start Date
March 1 2010
End Date
April 1 2013
Last Update
April 23 2013
Active Locations (2)
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1
Edogawa Hospital
Tokyo, Japan
2
Saiseikai Yokohama City Eastern Hospital
Yokohama, Japan, 230-8765