Coronary Artery Disease
Conditions
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.
Interventions
PROCEDUREstent 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
PROCEDUREstent 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
Sponsors
Saiseikai Yokohama City Eastern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of positive dipyridamole stress technetium scintigraphy | 7 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic restenosis rate in main vessel | 8 month | — |
| Fluoroscopic time | after procedure | — |
| Amount of contrast media | after procedure | — |
| Composite of major cardiac adverse events(MACE) | 8 month | Including cardiac death,myocardial infarction, stent thrombosis and target vessel revascularization |
| Diameter stenosis and late loss in side branch | 8 month | — |
| Regional summed difference score | 7 month | — |
| Number of stent and wire use | after procedure | — |
Countries
Japan
Outcome results
None listed