Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter Vasoguard TM in treatment of in-stent restenosis. Study group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM Control group: paclitaxel release coronary balloon catheter SeQuent Please
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
260
Zhongshan Hospital Fudan University
Beijing, Beijing Municipality, China
RECRUITINGLate Lumen Loss
Time frame: at 9 months
Device Success Rate
Time frame: at 9 months
Operation Success Rate
Time frame: at 9 months
Target lesion in-segment rate after operation 9 months
Time frame: at 9 months
Target lesion revascularization (TLR) and Target vessel revascularization (TVR) by clinical-driven
Time frame: at 9 months
Major adverse cardiovascular events (MACE) related with device, include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven
Time frame: at 9 months
Thrombotic events incidence (ARC definition include deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d)
Time frame: at 9 months
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