To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
236
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Drug-coated Coronary Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure
Late luminal loss (LLL)
Late luminal loss (LLL) within the target lesion segment at 9 months postoperatively
Time frame: 9 months after procedure
Device success rate
Successful delivery and dilatation of the drug-coating balloon catheter across lesion, and target lesion residual stenosis≤30% (visual inspection) without additional interventional treatment.
Time frame: Immediately after PTCA
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