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

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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Szabo T-Stenting Technique; Procedure: T-Stenting Technique

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongbo Yang, M.D.; Phone Number: 00862164223006 008613585890793; Email: yang.hongbo@zs-hospital.sh.cn
• Study Contact Backup: Name: Zheyong Huang, M.D.; Phone Number: 008613512100180; Email: huang.zheyong@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Not yet recruiting
    • Shanghai Zhongshan Hospital
    • Principal Investigator: Junbo Ge, Professor
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital
      • Contact: Hongbo Yang, M.D.; Phone Number: 13585890793; Email: yang.hongbo@zs-hospital.sh.cn
      • Contact: Zheyong Huang, M.D.; Phone Number: 13512100180; Email: huang.zheyong@zs-hospital.sh.cn
      • Principal Investigator: Junbo Ge, M.D.
      • Sub-Investigator: Zheyong Huang, M.D.
      • Sub-Investigator: Hongbo Yang, M.D.
      • Sub-Investigator: Jiatian Cao, M.D.
      • Sub-Investigator: Yanan Song, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Junbo Ge, Professor, Shanghai Zhongshan Hospital Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 2, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; bifurcation lesion; Szabo; T-stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: SZABO Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No