Bifurcation Lesion, Coronary Artery Disease
Conditions
Keywords
drug-coated balloon, percutaneous coronary intervention, drug-eluting stent, Yao strategy
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 increased risk of procedural complications. The study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo Medina type 0,1,0 or 0,0,1 bifurcation lesion. In view of the potential risks of using DCB alone in the treatment of de novo bifurcation lesions, the following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). The primary endpoint was late lumen loss and major adverse cardiovascular events.
Interventions
PROCEDUREDrug-coated balloon combined with provisional drug-eluting stent implantation
(1) DCB combined with provisional DES implantation 1-2 mm distally to the ostium lesion whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the ostium lesions followed by DCB treatment (DES+DCB strategy).
Sponsors
Xuzhou Third People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late lumen loss | 9 months follow-up | post-procedural minimum lumen diameter minus follow-up minimum lumen diameter. |
| major adverse cardiovascular events | 1 year | include cardiac death, non-fatal myocardial infarction, and target lesion revascularization. |
Contacts
Primary ContactYaojun Zhang, Dr
Outcome results
None listed