Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions

Cardiovascular Diseases Clinical Trial

Official title:

Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045039
• Other study ID #: HenanICE2023
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: Jin Gao, BD
• Phone: +86 371 58681130
• Email: gao-jin[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 = ?

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia
• Vascular Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure rate	cardiac death	3-12 months
Primary	Target lesion failure rate	target vessel myocardial infarction (TVMI)	6-12 months
Primary	Target lesion failure rate	clinically driven target lesion revascularization (TLR)	6-12 months
Secondary	minimum lumen area and lumen stenosis rate	minimum lumen area and lumen stenosis rate	6-12months