Clinical trial NCT06045039: Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions
Official title: Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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 ≥ Ⅲ
* 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

Primary outcomes:
measure: Target lesion failure rate
timeFrame: 3-12 months
measure: Target lesion failure rate
timeFrame: 6-12 months
measure: Target lesion failure rate
timeFrame: 6-12 months
Secondary outcomes:
measure: minimum lumen area and lumen stenosis rate
timeFrame: 6-12months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
Study officials:
affiliation: FF
name: Xianpei Wang, MD
role: STUDY_CHAIR
References: