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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03714802
• Other study ID #: SZABO Trial
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Hongbo Yang, M.D.
• Phone: 008613585890793
• Email: yang.hongbo[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Procedure:
• Szabo T-Stenting Technique
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.
• T-Stenting Technique
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.

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization	record in follow-up	1 year after coronary angiography
Secondary	rate of all cause death	Recorded in follow-up	30 days and 12 months after primary angiography
Secondary	rate of cardiac death rate	Recorded in follow-up	30 days and 12 months after primary angiography
Secondary	rate of recurrent myocardial infarction rate	Recorded in follow-up	30 days and 12 months after primary angiography
Secondary	rate of target vessel revascularization rate	Recorded in follow-up	30 days and 12 months after primary angiography
Secondary	rate of stent thrombosis	Recorded in follow-up	30 days and 12 months after primary angiography
Secondary	residual stenosis degree	Measured through intravenous ultrasound	Immediately after stent implantation and 12 months after primary angiography
Secondary	residual stenosis of side branch	Measured through angiography	Immediately after stent implantation and 12 months after primary angiography
Secondary	late lumen loss	Measured through intravenous ultrasound	index procedure and 12 months follow up