Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases: SZABO Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Szabo T-Stenting Technique
* Procedure: T-Stenting Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be at least ≥18 years of age. Lesions are eligible for percutaneous coronary intervention (PCI). Patient has stable/unstable angina or myocardial infarction (MI). Bifurcation lesions (Medina 1,1,1/0,1,1/1,0,1) without left main ostial lesions. Downstream lesions could be covered by two stents. Diameter of vessel ≥2.25mm Diameter stenosis in main vessel and side branch ≥ 50% by visual estimation. Exclusion Criteria: Severe tortuosity or calcification affected procedural success. Patient was allergic to the study stent or protocol-required concomitant medications. Patient is intolerable to dual anti-platelet therapy. Patient has any other serious medical illness that may reduce life expectancy to<12 months. Patient is a woman who is pregnant or nursing. Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure. Coronary restenosis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Szabo T-Stenting Technique<br>Patients received 2-stents implantation guided with Szabo technique in bifurcation lesion. | Procedure: Szabo T-Stenting Technique<br>* 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.<br>Procedure: T-Stenting Technique<br>* 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.<br>|
| Placebo Comparator: T-Stenting Technique<br>Patients received 2-stents implantation guided with T-stenting technique in bifurcation lesion. | Procedure: Szabo T-Stenting Technique<br>* 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.<br>Procedure: T-Stenting Technique<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization | record in follow-up | 1 year after coronary angiography | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bifurcation lesion, percutaneous coronary intervention, Szabo, T-stenting