The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category (SeQuent® Please).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
242
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China
In-segment late lumen loss of the target lesion
Time frame: 9 months
The success rate of intervention treatment: including device success, lesion success and clinical success
Time frame: 1-2 days
Occurrence rate of restenosis in the target lesions
Time frame: 9 months after the operation
Target lesion revascularization (TLR) rate
Time frame: 1, 6, 9, and 12 months after the operation
Target vessel revascularization (TVR) rate
Time frame: 1, 6, 9, and 12 months after the operation
Target lesion failure (TLF) rate
Time frame: 1, 6, 9, and 12 months after the operation
Occurrence rate of major adverse cardiovascular events
Time frame: 1, 6, 9, and 12 months after the operation
All adverse events and severe adverse events
Time frame: 1, 6, 9, and 12 months after the operation
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