Evaluating a new technique for treating coronary bifurcation lesions
Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions
This study is testing a new stent technique for treating complicated heart artery blockages to see if it works better than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Henan Institute of Cardiovascular Epidemiology Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06045039 on ClinicalTrials.gov |
What this trial studies
This study assesses the clinical efficacy of the stent-balloon-stent (SBS) technique for treating complex coronary bifurcation lesions. The SBS approach involves implanting a stent in the side branch followed by a stent in the main vessel, utilizing a drug balloon to ensure optimal opening of the side branch. Patients will undergo coronary angiography before and 6-12 months after the procedure to evaluate outcomes such as stenosis rate and target vessel failure. The study aims to compare the SBS technique's effectiveness against existing double stent strategies.
Who should consider this trial
Good fit: Ideal candidates include patients with evidence of myocardial ischemia and specific bifurcation lesion characteristics who can tolerate long-term antiplatelet therapy.
Not a fit: Patients with severe surgical contraindications or those who have previously undergone stent implantation for related lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could improve long-term outcomes for patients with complex coronary bifurcation lesions.
How similar studies have performed: While the SBS technique is a novel approach, existing studies on bifurcation lesions have shown varying degrees of success with different stenting strategies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhengzhou, Henan
- Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Jin Gao, BD
- Email: gao-jin@foxmail.com
- Phone: +86 371 58681130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.