Coronary Artery DiseaseNCT03714802
Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases
A study testing Szabo T-Stenting Technique and T-Stenting Technique in people with Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 2 sites in China.
Trial summary
The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Szabo T-Stenting Technique and T-Stenting Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Hongbo Yang, M.D., 13585890793, yang.hongbo@zs-hospital.sh.cn
Zheyong Huang, M.D., 13512100180, huang.zheyong@zs-hospital.sh.cn
- Not yet recruiting
Shanghai Zhongshan Hospital
Shanghai, 200032
Junbo Ge, Professor
About this study
Official title: 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.
Read the 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
- Being tested
- Szabo T-Stenting Technique, T-Stenting Technique
- Keywords
- bifurcation lesion, percutaneous coronary intervention, Szabo, T-stenting
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Szabo T-Stenting TechniqueProcedure or surgery
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 TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Szabo T-Stenting Technique | Experimental | Patients received 2-stents implantation guided with Szabo technique in bifurcation lesion. Receives: 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. Receives: Procedure: Szabo T-Stenting Technique; Procedure: T-Stenting Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization
record in follow-up
Measured: 1 year after coronary angiography
Secondary outcomes (8)
rate of all cause death
Recorded in follow-up
Measured: 30 days and 12 months after primary angiography
rate of cardiac death rate
Recorded in follow-up
Measured: 30 days and 12 months after primary angiography
rate of recurrent myocardial infarction rate
Recorded in follow-up
Measured: 30 days and 12 months after primary angiography
rate of target vessel revascularization rate
Recorded in follow-up
Measured: 30 days and 12 months after primary angiography
rate of stent thrombosis
Recorded in follow-up
Measured: 30 days and 12 months after primary angiography
residual stenosis degree
Measured through intravenous ultrasound
Measured: Immediately after stent implantation and 12 months after primary angiography
residual stenosis of side branch
Measured through angiography
Measured: Immediately after stent implantation and 12 months after primary angiography
late lumen loss
Measured through intravenous ultrasound
Measured: index procedure and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
- Investigators
- Junbo Ge, Professor, Principal investigator, Shanghai Zhongshan Hospital Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714802
- Sponsor's protocol ID
- SZABO Trial
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases: SZABO Trial
- ClinicalTrials.gov ID
- NCT03714802
- Acronym / sponsor ID
- SZABO Trial
- Conditions
- Coronary Artery Disease
- Keywords
- bifurcation lesion, percutaneous coronary intervention, Szabo, T-stenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Szabo T-Stenting Technique | Experimental | Procedure: Szabo T-Stenting Technique, Procedure: T-Stenting TechniquePatients received 2-stents implantation guided with Szabo technique in bifurcation lesion. |
| T-Stenting Technique | Placebo comparator | Procedure: Szabo T-Stenting Technique, Procedure: T-Stenting TechniquePatients received 2-stents implantation guided with T-stenting technique in bifurcation lesion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Szabo T-Stenting Technique2-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 or surgery | Szabo T-Stenting Technique, T-Stenting Technique |
| T-Stenting Technique2-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. | Procedure or surgery | Szabo T-Stenting Technique, T-Stenting Technique |
Primary outcome
Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization
Time frame: 1 year after coronary angiography
record in follow-up
8 secondary outcomes
rate of all cause death
Time frame: 30 days and 12 months after primary angiography
rate of cardiac death rate
Time frame: 30 days and 12 months after primary angiography
rate of recurrent myocardial infarction rate
Time frame: 30 days and 12 months after primary angiography
rate of target vessel revascularization rate
Time frame: 30 days and 12 months after primary angiography
rate of stent thrombosis
Time frame: 30 days and 12 months after primary angiography
residual stenosis degree
Time frame: Immediately after stent implantation and 12 months after primary angiography
residual stenosis of side branch
Time frame: Immediately after stent implantation and 12 months after primary angiography
late lumen loss
Time frame: index procedure and 12 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge, Professor principal investigator
Shanghai Zhongshan Hospital Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Szabo T-Stenting Technique and T-Stenting Technique in people with Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongbo Yang, M.D. (008613585890793 ext. 00862164223006, yang.hongbo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization (time frame: 1 year after coronary angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.