Dilation of stenosis in a primary bifurcation coronary artery lesion
Conditions
Interventions
Experimental group:Rapamycin eluted balloon catheter
The control group:Cheezhou drug elution balloon catheter
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female aged 18-80 years; 2. Evidence of symptomatic myocardial ischemia, stable or unstable angina, or stable recent myocardial infarction (occurring more than 7 days before enrollment, including non-ST-segment elevation and ST-segment elevation myocardial infarction); 3. Suitable for balloon angioplasty or stent implantation; 4. Subjects who are able to understand all the risks and benefits stated in the informed consent documents, who voluntarily participate in the study, sign the written informed consent and are able to receive follow-up visits; 5. Angiography showed that the target lesion was bifurcation lesion and the primary lesion; 6. Visual measurement of the stenosis degree of the target lesion branch vessel opening diameter >= 70%; 7. The main and branch vessels are suitable for PCI and stent treatment, and dual-stent technology is not considered for branch lesions; 8. The diameter of branch vessels is 2.0 ~ 4.0mm, and the lesion length is less than or equal to 40mm.
Exclusion criteria
Exclusion criteria: 1. Patients with severe renal insufficiency (creatinine > 200umol/L) or treated with renal dialysis; 2. Known allergy to rapamycin and its derivatives; 3. Myocardial infarction occurred within one week before enrollment; 4. Stroke occurred within 6 months before enrollment, excluding TIA and luminal infarction; 5. Patients with a definite bleeding tendency, a history of cerebral hemorrhage or subarachnoid hemorrhage within 6 months, a history of active gastrointestinal ulcer bleeding, contraindications to antiplatelet preparations and anticoagulants, and unable to receive anticoagulant therapy; 6. Patients with severe heart failure (NYHA Grade IV); 7. Life expectancy is less than 1 year or is expected to be difficult to complete a 1-year follow-up; 8. Pregnant or lactating women, or patients who had family planning or were unable to use adequate contraception at the time of the study; 9. Participating in clinical trials of other drugs or devices that do not meet the primary endpoint; 10. For other reasons, researchers consider it unsuitable for inclusion. 11. Angiography showed thrombus in the target lesion; 12. Complete occlusion of target lesion; 13. Left main lesion and its bifurcation; 14. Severe calcification of the branching vessel target and failure to predilate or use double balloon to dilate the snout; 15. The branch vessel target lesions were stent restenosis lesions; 16. Grade C dissection or > 50% restenosis after predilation of branch vessel target lesion or dilation of double balloon to snout.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The lesion diameter stenosis degree of target lesion branch vessels 9 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of interventional therapy;The incidence of restenosis of target lesion branch vessels 9 months after operation;Nine months after operation, the target lesion branch vascular disease in the segmental changes of the late lumen loss;The incidence of major adverse cardiovascular events at 30 days, 6, 9, 12 months, and 2 years after surgery;Device related cardiovascular clinical composite endpoints at 30 days, 6, 9, 12 months, and 2 years postoperatively;Identified and probable thrombosis, including acute, subacute, late, and late thrombosis;All adverse events and serious adverse events occurred at 30 days, 6, 9, 12 months, and 2 years after surgery; | — |
Countries
China
Contacts
Public ContactYujie Zhou
Beijing Anzhen Hospital
Outcome results
None listed