Coronary artery stenosis
Conditions
Interventions
RESTORE DEB paclitaxel releasing PTCA balloon catheter group:Nil
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subjects must be at least 18 years of age; 2.Subjects participate in this study voluntarily and sign the informed consent form; 3.The authors suggest that RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter is suitable for patients with coronary artery restenosis or primary coronary artery disease.
Exclusion criteria
Exclusion criteria: 1.Life expectancy less than 2 years; 2.Patients with known contraindications to PCI or DCB: (1)Known to be allergic to any component of the drugs or research devices necessary for the operation, such as aspirin, clopidogrel, heparin, contrast agent, ticagrelor, bivalirudin, paclitaxel, shellac ammonium salt; (2)The subjects had bleeding tendency, active peptic ulcer, history of cerebral hemorrhage or subarachnoid hemorrhage, and stroke within the past 6 months; (3)Unprotected left main artery lesions or CTO lesions; (4)Pregnant, unable to exclude pregnant or nursing subjects. 3.Subject is currently participating in another clinical study of drugs or medical devices; 4.Subject is unsuitable for the study according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| target lesion failure;cardiac death;target vessel myocardial infarction;ischemic-driven target lesion revascularization;stent thrombosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of device success during the procedure;rate of all-cause death;incidence rate of myocardial infarction;target vessel revascularization;target lesion revascularization;target lesion failure;patient-oriented composite endpoint;Bleeding Academic Research Federation (BARC) level 2, 3, 5 bleeding events;stent thrombosis; | — |
Countries
China
Contacts
Public ContactJi Fusui
Beijing Hospital
Outcome results
None listed