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Search / Trial NCT06045039

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

Launched by HENAN INSTITUTE OF CARDIOVASCULAR EPIDEMIOLOGY · Sep 13, 2023

Trial Information

Current as of November 08, 2025

Recruiting

Keywords

Angioplasty Coronary Angiography Surgery Coronary Vessels Diagnostic Imaging Pathology Drug Eluting Stents Treatment Outcome

ClinConnect Summary

This clinical trial is studying a new treatment approach called the stent-balloon-stent (SBS) technique for patients with coronary bifurcation lesions, which are blockages that occur at the branching points of arteries supplying blood to the heart. The SBS technique aims to improve blood flow by carefully opening up these branches, potentially leading to better long-term outcomes for patients compared to traditional methods. The trial will assess how safe and effective this technique is for treating patients with conditions like stable angina (chest pain) and acute myocardial infarction (heart attack).

To be eligible for the trial, participants should be between 65 and 74 years old and must have specific types of artery blockages that meet certain criteria. They should be able to take long-term medication to prevent blood clots, and they should not have had previous stent procedures in the affected arteries. Participants who join the study can expect close monitoring and care from medical professionals throughout the trial, contributing valuable information that could help improve treatment for future patients with similar heart issues.

Gender

ALL

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

About Henan Institute Of Cardiovascular Epidemiology

The Henan Institute of Cardiovascular Epidemiology is a leading research organization dedicated to advancing the understanding of cardiovascular diseases through rigorous epidemiological studies. Based in Henan Province, China, the institute focuses on the prevention, diagnosis, and treatment of cardiovascular conditions by conducting innovative clinical trials and population-based research. Committed to improving public health outcomes, the institute collaborates with national and international partners to disseminate findings that inform clinical practices and health policies. With a multidisciplinary team of experts, the Henan Institute of Cardiovascular Epidemiology plays a pivotal role in shaping cardiovascular health initiatives and enhancing patient care.

Locations

Zhengzhou, Henan, China

Patients applied

0 patients applied

Trial Officials

Xianpei Wang, MD

Study Chair

FF

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported