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

NCT ID: NCT03714802

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2024-12-31

Brief Summary

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

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Szabo T-Stenting Technique

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

Group Type: EXPERIMENTAL

Szabo T-Stenting Technique

Intervention Type: 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.

T-Stenting Technique

Intervention Type: 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.

T-Stenting Technique

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

Group Type: PLACEBO_COMPARATOR

Szabo T-Stenting Technique

Intervention Type: 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.

T-Stenting Technique

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junbo Ge

Professor Ge

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junbo Ge, Professor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital Fudan University

Locations

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Shanghai Zhongshan Hospital

Shanghai, , China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Hongbo Yang, M.D.

Role: CONTACT

yang.hongbo@zs-hospital.sh.cn

008613585890793 ext. 00862164223006

Zheyong Huang, M.D.

Role: CONTACT

huang.zheyong@zs-hospital.sh.cn

008613512100180

Facility Contacts

Hongbo Yang, M.D.

Role: primary

yang.hongbo@zs-hospital.sh.cn

13585890793

Zheyong Huang, M.D.

Role: backup

huang.zheyong@zs-hospital.sh.cn

13512100180

Other Identifiers

SZABO Trial

Identifier Type: -

Identifier Source: org_study_id