Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions
NCT06045039
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.
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 ≥ 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
Conditions6
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NCT06045039