Coronary DiseaseNCT06045039
Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions
An observational study of Coronary Disease and Heart Diseases, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
The treatment of coronary bifurcation lesions continue to remain challenges. Due to the special hemodynamics caused by the special anatomical structure of the coronary bifurcation, it is easy to cause vascular crest displacement and plaque formation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Disease, Heart Diseases, Cardiovascular Diseases
- What is being tested?
- Stent-balloon-stent (SBS) technique
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had evidence of myocardial ischemia and received interventional therapy for coronary bifurcation lesions in our center from January 2023 to December 2023.
Who may be able to join
- There is evidence of myocardial ischemia, such as coronary angiography, including patients with stable angina pectoris, unstable angina pectoris, asymptomatic myocardial ischemia and acute myocardial infarction (> 24 hours).
- All bifurcation lesions were Medina 1, 1, 1 or 0, 1, 1 with reference vessel diameter (RVD) in the SB ≥2.5 mm by visual estimation and had to meet DEFINITION criteria of complex bifurcations
- Patients who can tolerate long-term antiplatelet therapy
- None of the vessels related to bifurcation lesions have received stent surgery
- Patients who agree and sign an informed consent form
Who cannot join
- Patients who are unwilling to sign the relevant informed consent form
- Patients with severe surgical contraindications
- Life expectancy of patients is less than 12 months
- Patients who have previously undergone stent implantation or surgical coronary artery bypass grafting for related lesions
- Patients with severe hepatorenal insufficiency
- Heart failure patients with NYHA grade ≥ Ⅲ
Show all 10Show fewer
- Patients who are scheduled for surgery requiring antiplatelet medication interruption within 6 months
- Patients who need chronic oral anticoagulation
- Any clinical condition of the patient may interfere with medication compliance or long-term follow-up
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
About this study
The treatment of coronary bifurcation lesions continue to remain challenges. Due to the special hemodynamics caused by the special anatomical structure of the coronary bifurcation, it is easy to cause vascular crest displacement and plaque formation. The existing single-stent strategy and double-stent strategy are easy to cause vascular crest offset, stent accumulation, in-stent thrombosis, in-stent restenosis and other poor long-term prognosis. Stent-balloon-stent (Stent-balloon-stent, SBS) technique enables the guide wire to enter the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².The SBS technique reduces the risk of branch vascular dissection, occlusion, snow shoveling phenomenon, maintain the original state of bifurcated blood vessels to the greatest extent, should have a good impact on the long-term prognosis of patients with coronary bifurcation lesions (CBL). The purpose of this study is to explore the feasibility, safety and effectiveness of SBS technique.
Read the detailed description
This is a study to evaluate the application of stent-balloon-stent (Stent-balloon-stent, SBS) in complex bifurcation lesions. 1-2mm from the side branch (SB) opening, the stent was implanted in the side branch, and then the stent was implanted in the main vessel (MV).The guide wire enters the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².The patients were examined by coronary angiography before operation and 6-12 months after operation, and the related data such as stenosis rate and minimum lumen diameter of diseased vessels were recorded. The incidence of target vessel failure (TLF) 6-12 months later, including cardiogenic death, target vessel myocardial infarction and clinically driven target vessel revascularization, was taken as the main clinical end point. The corresponding data of the patients before and after operation were obtained, and the clinical efficacy was compared with the existing double stent strategy.
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Myocardial Ischemia
- Being tested
- Stent-balloon-stent (SBS) technique
- Keywords
- Angioplasty, Coronary Angiography, surgery, Coronary Vessels, diagnostic imaging, pathology, Drug-Eluting Stents, Treatment Outcome
- Medical subject headings
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent-balloon-stent (SBS) techniqueOther
Patients with coronary bifurcation lesions underwent stent-balloon-stent (SBS) technique. The procedure of this technique is to implant the stent into the side branch at the 1~2mm, which is away from the opening of the branch, and then implant the stent into the main vessel. The guide wire enters the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².
| Study group | Role | What they receive |
|---|---|---|
| Stent-balloon-stent (SBS) technique | Patients with coronary bifurcation lesions underwent stent-balloon-stent (SBS) technique. The procedure of this technique is to implant the stent into the side branch at the 1~2mm, which is away from the opening of the branch, and then implant the stent into the main vessel. The guide wire enters the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm². Receives: Other: Stent-balloon-stent (SBS) technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure rate
cardiac death
Measured: 3-12 months
Target lesion failure rate
target vessel myocardial infarction (TVMI)
Measured: 6-12 months
Target lesion failure rate
clinically driven target lesion revascularization (TLR)
Measured: 6-12 months
Secondary outcomes (1)
minimum lumen area and lumen stenosis rate
minimum lumen area and lumen stenosis rate
Measured: 6-12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianpei Wang, Henan Institute of Cardiovascular Epidemiology
- Investigators
- Xianpei Wang, MD, Study chair, FF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045039
- Sponsor's protocol ID
- HenanICE2023
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Others can obtain the individual participant data from the researcher by reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT06045039
- Acronym / sponsor ID
- HenanICE2023
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Myocardial Ischemia
- Keywords
- Angioplasty, Coronary Angiography, surgery, Coronary Vessels, diagnostic imaging, pathology, Drug-Eluting Stents, Treatment Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (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 treatment of coronary bifurcation lesions continue to remain challenges. Due to the special hemodynamics caused by the special anatomical structure of the coronary bifurcation, it is easy to cause vascular crest displacement and plaque formation. The existing single-stent strategy and double-stent strategy are easy to cause vascular crest offset, stent accumulation, in-stent thrombosis, in-stent restenosis and other poor long-term prognosis. Stent-balloon-stent (Stent-balloon-stent, SBS) technique enables the guide wire to enter the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².The SBS technique reduces the risk of branch vascular dissection, occlusion, snow shoveling phenomenon, maintain the original state of bifurcated blood vessels to the greatest extent, should have a good impact on the long-term prognosis of patients with coronary bifurcation lesions (CBL). The purpose of this study is to explore the feasibility, safety and effectiveness of SBS technique.
Detailed description
This is a study to evaluate the application of stent-balloon-stent (Stent-balloon-stent, SBS) in complex bifurcation lesions. 1-2mm from the side branch (SB) opening, the stent was implanted in the side branch, and then the stent was implanted in the main vessel (MV).The guide wire enters the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm².The patients were examined by coronary angiography before operation and 6-12 months after operation, and the related data such as stenosis rate and minimum lumen diameter of diseased vessels were recorded. The incidence of target vessel failure (TLF) 6-12 months later, including cardiogenic death, target vessel myocardial infarction and clinically driven target vessel revascularization, was taken as the main clinical end point. The corresponding data of the patients before and after operation were obtained, and the clinical efficacy was compared with the existing double stent strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent-balloon-stent (SBS) technique | – | Other: Stent-balloon-stent (SBS) techniquePatients with coronary bifurcation lesions underwent stent-balloon-stent (SBS) technique. The procedure of this technique is to implant the stent into the side branch at the 1~2mm, which is away from the opening of the branch, and then implant the stent into the main vessel. The guide wire enters the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm². |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had evidence of myocardial ischemia and received interventional therapy for coronary bifurcation lesions in our center from January 2023 to December 2023.
Key inclusion criteria (5 listed)
- There is evidence of myocardial ischemia, such as coronary angiography, including patients with stable angina pectoris, unstable angina pectoris, asymptomatic myocardial ischemia and acute myocardial infarction (> 24 hours).
- All bifurcation lesions were Medina 1, 1, 1 or 0, 1, 1 with reference vessel diameter (RVD) in the SB ≥2.5 mm by visual estimation and had to meet DEFINITION criteria of complex bifurcations
- Patients who can tolerate long-term antiplatelet therapy
- None of the vessels related to bifurcation lesions have received stent surgery
- Patients who agree and sign an informed consent form
Key exclusion criteria (10 listed)
- Patients who are unwilling to sign the relevant informed consent form
- Patients with severe surgical contraindications
- Life expectancy of patients is less than 12 months
- Patients who have previously undergone stent implantation or surgical coronary artery bypass grafting for related lesions
- Patients with severe hepatorenal insufficiency
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 |
|---|---|---|
| Stent-balloon-stent (SBS) techniquePatients with coronary bifurcation lesions underwent stent-balloon-stent (SBS) technique. The procedure of this technique is to implant the stent into the side branch at the 1~2mm, which is away from the opening of the branch, and then implant the stent into the main vessel. The guide wire enters the side branch from the mesh at the distal end of the main vascular stent, and the drug balloon is used to dilate the opening of the side branch, so that the opening area of the side branch is more than 5mm². | Other | Stent-balloon-stent (SBS) technique |
Primary outcome
Target lesion failure rate
Time frame: 3-12 months
cardiac death
Target lesion failure rate
Time frame: 6-12 months
target vessel myocardial infarction (TVMI)
Target lesion failure rate
Time frame: 6-12 months
clinically driven target lesion revascularization (TLR)
1 secondary outcome
minimum lumen area and lumen stenosis rate
Time frame: 6-12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No. Others can obtain the individual participant data from the researcher by reasonable request
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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.
Xianpei Wang, MD study chair
FF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Heart Diseases, run by Henan Institute of Cardiovascular Epidemiology at 1 site 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 5 inclusion and 10 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Jin Gao, BD (+86 371 58681130, gao-jin@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure rate (time frame: 3-12 months). The study lists 3 primary outcomes in all. 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 28 Feb 2024.