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The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases.
Accurate deployment of stents in ostial lesions is difficult with traditional angiographic guidance. Szabo technique, which used a second angioplasty guide wire to anchor the stent by passing the proximal end of the anchor wire through the last cell of the stent, demonstrated accurate placement of the stents in ostial locations. In bifurcation lesions, 2-stent strategy positioning with Szabo technique was not investigated. Modified T-stenting with Szabo technique may improve prognosis of bifurcation lesions through reducing stents overlap. There is no clinical trial focuses on the effect and outcome of Szabo technique for coronary artery bifurcation lesions in contrast with conventional strategy.
In this study, the authors choose the closest 2-stent strategy, T-stenting, as control. We hope to determine whether a planned Szabo 2-stent technique is superior to T-stenting for patients with bifurcation lesions.
Patients with bifurcation lesions will be randomly assigned to receive Szabo 2-stent technique or T-stenting strategy. Clinical outcomes and imaging assessment will be used to estimate their effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Szabo T-Stenting Technique | Experimental | Patients received 2-stents implantation guided with Szabo technique in bifurcation lesion. |
|
| T-Stenting Technique | Placebo Comparator | Patients received 2-stents implantation guided with T-stenting technique in bifurcation lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Szabo T-Stenting Technique | Procedure | 2-stent strategy was performed using modified T-stenting with Szabo technique in bifurcation lesions. First, stent was implanted in the side branch with Szabo technique. Then, stent was implanted in the main branch. Finally, kissing balloon inflation was performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization | record in follow-up | 1 year after coronary angiography |
| Measure | Description | Time Frame |
|---|---|---|
| rate of all cause death | Recorded in follow-up | 30 days and 12 months after primary angiography |
| rate of cardiac death rate | Recorded in follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongbo Yang, M.D. | Contact | 008613585890793 | 00862164223006 | yang.hongbo@zs-hospital.sh.cn |
| Zheyong Huang, M.D. | Contact | 008613512100180 | huang.zheyong@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, Professor | Shanghai Zhongshan Hospital Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| T-Stenting Technique | Procedure | 2-stent strategy was performed using traditional T-stenting technique in bifurcation lesions. First, stent was implanted in the side branch with angiographic guidance. Then, stent was implanted in the main branch. Finally, kissing balloon inflation was performed. |
|
| 30 days and 12 months after primary angiography |
| rate of recurrent myocardial infarction rate | Recorded in follow-up | 30 days and 12 months after primary angiography |
| rate of target vessel revascularization rate | Recorded in follow-up | 30 days and 12 months after primary angiography |
| rate of stent thrombosis | Recorded in follow-up | 30 days and 12 months after primary angiography |
| residual stenosis degree | Measured through intravenous ultrasound | Immediately after stent implantation and 12 months after primary angiography |
| residual stenosis of side branch | Measured through angiography | Immediately after stent implantation and 12 months after primary angiography |
| late lumen loss | Measured through intravenous ultrasound | index procedure and 12 months follow up |
| Shanghai Zhongshan Hospital | Not yet recruiting | Shanghai | 200032 | China |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |