Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion

Launched by XUZHOU THIRD PEOPLE'S HOSPITAL · Dec 3, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating new treatment approaches for patients with a specific type of heart condition called coronary artery disease, specifically focusing on bifurcation lesions (where a blood vessel branches). The study aims to find out which of two treatment strategies is more effective and safe for patients with these lesions. The two methods being tested involve using special types of balloon catheters and stents to open up blocked arteries. The trial will include 200 patients who have certain types of bifurcation lesions and who meet specific health criteria.

To participate in this study, individuals must be between 18 and 80 years old and have a specific type of blockage in their coronary arteries. They should also be willing to sign consent forms and attend follow-up appointments. Participants can expect to receive either a combination of treatments or a different sequence of treatments, and the study will monitor their heart health over time to see how well the treatments work and if there are any serious complications. It's important to note that some people may not be eligible due to certain health conditions or recent medical history.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects at the age between ≥18 and ≤80 years old;
• • 2. De novo native lesion, Median type 010/001 bifurcation lesion;
• • 3. The reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm;
• • 4. Subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up.
• Exclusion Criteria:
• • 1. The diameter stenosis of adjacent branch vessel ostium ≥50%;
• • 2. Acute ST-segment elevation myocardial infarction;
• • 3. Stents implanted within 10 mm proximal or distal to the target lesion;
• • 4. Aneurysm within 10 mm proximal or distal to the target lesion;
• • 5. There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass;
• • 6. Previous coronary artery bypass grafting;
• • 7. Evidence for extensive thrombus within target vessel;
• • 8. Evidence of heart failure by at least one of the following: a. Most recent LVEF ≤35%, or b. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or c. Killip class ≥2 (post STEMI patients);
• • 9. Subjects with a life expectancy of ≤1 year;
• • 10. Subjects with stroke, peptic ulcer, or gastrointestinal bleeding within the past 6 months;
• • 11. Subjects with severe renal failure (eGFR\<30ml/minute), failure to comply with angiography conditions;
• • 12. Subjects who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications;
• • 13. Subjects who are intolerance or allergic to heparin, contrast agent;
• • 14. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
• • 15. Subjects who are not applicable to be enrolled by investigators due to other reasons.