Clinical trial NCT01238510: Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Saiseikai Yokohama City Eastern Hospital
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: Rate of positive dipyridamole stress technetium scintigraphy
timeFrame: 7 month
Secondary outcomes:
measure: Composite of major cardiac adverse events(MACE)
timeFrame: 8 month
measure: Angiographic restenosis rate in main vessel
timeFrame: 8 month
measure: Fluoroscopic time
timeFrame: after procedure
measure: Amount of contrast media
timeFrame: after procedure
measure: Number of stent and wire use
timeFrame: after procedure
measure: Diameter stenosis and late loss in side branch
timeFrame: 8 month
measure: Regional summed difference score
timeFrame: 7 month
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Edogawa Hospital
city: Yokohama
country: Japan
facility: Saiseikai Yokohama City Eastern Hospital
Study officials:
affiliation: Saiseikai Yokohama City Eastern Hospital
name: Masahiro Yamawaki, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: