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

Fudan University

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: T-Stenting Technique; Procedure: Szabo T-Stenting Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03714802

SZABO Trial

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Szabo T-Stenting Technique

Experimental group

Description:

Patients received 2-stents implantation guided with Szabo technique in bifurcation lesion.

Treatment:

Procedure: T-Stenting Technique

Procedure: Szabo T-Stenting Technique

T-Stenting Technique

Placebo Comparator group

Description:

Patients received 2-stents implantation guided with T-stenting technique in bifurcation lesion.

Treatment:

Procedure: T-Stenting Technique

Procedure: Szabo T-Stenting Technique