Status:
RECRUITING
Clinical Efficacy of Stent-balloon-stent (SBS) Technique in the Treatment of Coronary Bifurcation Lesions
Lead Sponsor:
Henan Institute of Cardiovascular Epidemiology
Conditions:
Coronary Disease
Heart Diseases
Eligibility:
All Genders
18-85 years
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...
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 si...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06045039
Start Date
January 1 2023
End Date
December 31 2024
Last Update
February 28 2024
Active Locations (1)
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1
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China