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

Primary Purpose

Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Szabo T-Stenting Technique

T-Stenting Technique

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring bifurcation lesion, percutaneous coronary intervention, Szabo, T-stenting

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Zhongshan HospitalRecruiting
Shanghai Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Szabo T-Stenting Technique

T-Stenting Technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

record in follow-up

Secondary Outcome Measures

rate of all cause death

Recorded in follow-up

rate of cardiac death rate

Recorded in follow-up

rate of recurrent myocardial infarction rate

Recorded in follow-up

rate of target vessel revascularization rate

Recorded in follow-up

rate of stent thrombosis

Recorded in follow-up

residual stenosis degree

Measured through intravenous ultrasound

residual stenosis of side branch

Measured through angiography

late lumen loss

Measured through intravenous ultrasound

Full Information

NCT ID

NCT03714802

First Posted

September 21, 2018

Last Updated

March 2, 2019

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03714802

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Szabo T-Stenting Technique

Arm Type

Experimental

Arm Description

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

Arm Title

T-Stenting Technique

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Szabo T-Stenting Technique

Intervention Description

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

Intervention Name(s)

T-Stenting Technique

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

record in follow-up

Time Frame

1 year after coronary angiography

Secondary Outcome Measure Information:

Title

rate of all cause death

Description

Recorded in follow-up

Time Frame

30 days and 12 months after primary angiography

Title

rate of cardiac death rate

Description

Recorded in follow-up

Time Frame

30 days and 12 months after primary angiography

Title

rate of recurrent myocardial infarction rate

Description

Recorded in follow-up

Time Frame

30 days and 12 months after primary angiography

Title

rate of target vessel revascularization rate

Description

Recorded in follow-up

Time Frame

30 days and 12 months after primary angiography

Title

rate of stent thrombosis

Description

Recorded in follow-up

Time Frame

30 days and 12 months after primary angiography

Title

residual stenosis degree

Description

Measured through intravenous ultrasound

Time Frame

Immediately after stent implantation and 12 months after primary angiography

Title

residual stenosis of side branch

Description

Measured through angiography

Time Frame

Immediately after stent implantation and 12 months after primary angiography

Title

late lumen loss

Description

Measured through intravenous ultrasound

Time Frame

index procedure and 12 months follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hongbo Yang, M.D.

Phone

008613585890793

Ext

00862164223006

yang.hongbo@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zheyong Huang, M.D.

Phone

008613512100180

huang.zheyong@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junbo Ge, Professor

Organizational Affiliation

Shanghai Zhongshan Hospital Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongbo Yang, M.D.

Phone

13585890793

yang.hongbo@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Zheyong Huang, M.D.

Phone

13512100180

huang.zheyong@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Junbo Ge, M.D.

First Name & Middle Initial & Last Name & Degree

Zheyong Huang, M.D.

First Name & Middle Initial & Last Name & Degree

Hongbo Yang, M.D.

First Name & Middle Initial & Last Name & Degree

Jiatian Cao, M.D.

First Name & Middle Initial & Last Name & Degree

Yanan Song, M.D.

Facility Name

Shanghai Zhongshan Hospital

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junbo Ge, Professor

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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