Coronary artery lesions in situ
Conditions
Interventions
experimental group:PTCA drug balloon catheter
control group:Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 = 70% (visual inspection) or >= 50% (visual inspection) with evidence of ischemia; 4. Reference vessel diameter 2.5mm-4.0mm, length of single target lesion <= 35mm; The total length of the lesion does not exceed 60mm; 5. All lesions are located in 1 or 2 different coronary arteries (RCA/LAD/LCX). Each patient is allowed to have at most 2 target lesions requiring interventional treatment, and each target vessel can only be treated with one test device; 6. The number of non target lesions requiring interventional therapy is up to 2, and they cannot be in the same vessel as the target lesions.Randomization should be performed after successful treatment of non-target lesions; 7. Patients who understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to follow up the study.
Exclusion criteria
Exclusion criteria: 1. Patients who have experienced myocardial infarction within the past week (<7 days); 2. Evidence of substantial thrombus in the target vessel; 3. Patients with severe renal impairment (glomerular filtration rate (GFR) <30ml/min) or undergoing haemodialysis; 4. Patients scheduled for other cardiovascular or cerebrovascular surgery within 12 months of the initial procedure; 5. Patients with a bleeding tendency, history of active gastrointestinal ulceration, stroke within 6 months prior to surgery, or contraindications to antiplatelet agents and anticoagulants rendering anticoagulation therapy unfeasible; 6. Subjects with a life expectancy of less than 1 year; 7. Pregnant or lactating women; 8. Patients with allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast media, or paclitaxel; or those with systemic lupus erythematosus or other systemic autoimmune diseases; 9. Chronic total occlusion (CTO); 10. Unprotected left main lesions; 11. Bifurcated lesions where the operator elects dual-stent treatment; 12. Left main lesions or lesions with an ostial distance =2mm from the left main; 13. Severely calcified or tortuous lesions unsuitable for successful pre-dilation, drug-coated balloon delivery, or expansion; 14. Coronary artery bypass graft lesions; 15. In-stent restenosis lesions; 16. Presence of myocardial bridge at the target lesion site; 17. Subjects currently participating in another drug or device clinical trial that has not yet completed its primary endpoint; 18. Subjects deemed by the investigator to be unable to comply with the study protocol requirements or otherwise considered unsuitable for participation in the study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fractional flow reserve(FFR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Late lumen loss(LLL) in the diseased segment;Surgical success rate (including instrument success, lesion success, and surgical success);Percentage of intrasegmental diameter stenosis(DS%);Restenosis rate of target lesion (degree of diameter stenosis% = 50%);Target lesion failure (TLF);Patient-oriented composite endpoint(POCE);Incidence of thrombotic events; | — |
Countries
China
Contacts
Public ContactTao Ling
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed