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

NCT03714802 | Unknown DMC

• 1 other identifier: SZABO Trial
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Keywords

bifurcation lesion; percutaneous coronary intervention; Szabo; T-stenting

Outcome Measures

Primary Outcomes (1)

• Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization

  record in follow-up

  1 year after coronary angiography

Secondary Outcomes (8)

• rate of all cause death

  30 days and 12 months after primary angiography

• rate of cardiac death rate

  30 days and 12 months after primary angiography

• rate of recurrent myocardial infarction rate

  30 days and 12 months after primary angiography

• rate of target vessel revascularization rate

  30 days and 12 months after primary angiography

• rate of stent thrombosis

  30 days and 12 months after primary angiography

Study Arms (2)

Szabo T-Stenting Technique

EXPERIMENTAL

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

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

T-Stenting Technique

PLACEBO COMPARATOR

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

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

Interventions

Szabo T-Stenting Technique 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.

Szabo T-Stenting Technique; T-Stenting Technique

T-Stenting Technique 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.

Szabo T-Stenting Technique; T-Stenting Technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (2)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, 200032, China

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Junbo Ge, Professor

  Shanghai Zhongshan Hospital Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbo Yang, M.D.

CONTACT

008613585890793; yang.hongbo@zs-hospital.sh.cn

Zheyong Huang, M.D.

CONTACT

008613512100180; huang.zheyong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ge

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: October 22, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 5, 2019

Record last verified: 2018-10

Locations

CN (2)