Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions. (PROTECT-SB)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Procedure: stent technique: Provisional fKBT Procedure: stent technique: Routine fKBT |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- Rate of positive dipyridamole stress technetium scintigraphy [ Time Frame: 7 month ] [ Designated as safety issue: Yes ]
- Composite of major cardiac adverse events(MACE) [ Time Frame: 8 month ] [ Designated as safety issue: Yes ]Including cardiac death,myocardial infarction, stent thrombosis and target vessel revascularization
- Angiographic restenosis rate in main vessel [ Time Frame: 8 month ] [ Designated as safety issue: No ]
- Fluoroscopic time [ Time Frame: after procedure ] [ Designated as safety issue: No ]
- Amount of contrast media [ Time Frame: after procedure ] [ Designated as safety issue: No ]
- Number of stent and wire use [ Time Frame: after procedure ] [ Designated as safety issue: No ]
- Diameter stenosis and late loss in side branch [ Time Frame: 8 month ] [ Designated as safety issue: No ]
- Regional summed difference score [ Time Frame: 7 month ] [ Designated as safety issue: Yes ]
| Enrollment: | 120 |
| Study Start Date: | March 2010 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Provisional fKBT
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
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 |
|
Active Comparator: Routine fKBT
Stent technique that fKBT was mandatory irrespective of side branch flow after stenting.
|
Procedure: stent 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 |
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| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts 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,
Contacts and Locations| Japan | |
| Edogawa Hospital | |
| Tokyo, Japan | |
| Saiseikai Yokohama City Eastern Hospital | |
| Yokohama, Japan, 230-8765 | |
| Principal Investigator: | Masahiro Yamawaki, MD,PhD | Saiseikai Yokohama City Eastern Hospital |
More Information
No publications provided
| Responsible Party: | Masahiro Yamawaki, Cardiology, Saiseikai Yokohama City Eastern Hospital |
| ClinicalTrials.gov Identifier: | NCT01238510 History of Changes |
| Other Study ID Numbers: | 2009009 |
| Study First Received: | November 9, 2010 |
| Last Updated: | April 22, 2013 |
| Health Authority: | Japan: Institutional Review Board |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013