Status:
NOT_YET_RECRUITING
Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion
Lead Sponsor:
Xuzhou Third People's Hospital
Conditions:
Coronary Artery Disease
Bifurcation Lesion
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increa...
Eligibility Criteria
Inclusion
- Subjects at the age between ≥18 and ≤80 years old;
- De novo native lesion, Median type 010/001 bifurcation lesion;
- The reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm;
- Subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up.
Exclusion
- The diameter stenosis of adjacent branch vessel ostium ≥50%;
- Acute ST-segment elevation myocardial infarction;
- Stents implanted within 10 mm proximal or distal to the target lesion;
- Aneurysm within 10 mm proximal or distal to the target lesion;
- There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass;
- Previous coronary artery bypass grafting;
- Evidence for extensive thrombus within target vessel;
- 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);
- Subjects with a life expectancy of ≤1 year;
- Subjects with stroke, peptic ulcer, or gastrointestinal bleeding within the past 6 months;
- Subjects with severe renal failure (eGFR\<30ml/minute), failure to comply with angiography conditions;
- Subjects who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications;
- Subjects who are intolerance or allergic to heparin, contrast agent;
- Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
- Subjects who are not applicable to be enrolled by investigators due to other reasons.
Key Trial Info
Start Date :
April 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06166459
Start Date
April 22 2024
End Date
March 1 2026
Last Update
March 27 2024
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