This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent restenosis compared to seQuent® please paclitaxel drug-coated coronary artery balloon catheter.
This prospective, multicenter, randomized controlled clinical study is designed to enroll 216 subjects with in-stent restenosis and randomly assign them to the trial and control groups on a 1:1 basis.The experimental group was treated with paclitaxel drug-coated coronary artery balloon catheter, and the control group was treated with SeQuent ® Please paclitaxel balloon catheter, which has been marketed. In-segment late lumen loss 9 months after surgery was the main end point of the study. All subjects were followed up clinically at 1 month, 6 months, 9 months, 1 year and 2 years after the surgery, and were followed up with angiography at 9 months after the surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
216
treat the petients with coronary artery in-stent restenosis
In-segment Late Lumen Loss
In-segment Late Lumen Loss
Time frame: 9 months after coronary angiography
Device success
defined as residual stenosis ≤30% and TIMI3 blood flow after drug-eluting balloon dilation.
Time frame: during the procedure
Procedural success
Defined as target lesions with residual stenosis ≤30% and TIMI3 blood flow after any interventional treatment, without thrombus or dissection need interention.
Time frame: Immediately after the index procedure
Clinical success
Defined as the absence of device-related composite endpoint events during hospitalization (up to 7 days after surgery) on the basis of procedural success.
Time frame: At time of procedure up to 7 days in hospital
Device-oriented composite endpoints (Target Lesion Failure)
TLF is defined as the composited endpoints of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization.
Time frame: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure
Patient-oriented composite endpoint (PoCE)
Patient-oriented composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.
Time frame: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure
Death (Cardiac, Non-cardiac)
Defined as death due to the following causes. Acute myocardial infarction; cardiac perforation/cardiac tamponade; arrhythmia or abnormal conduction; death due to surgical complications, including bleeding, vascular repair, transfusion response, or coronary artery bypass surgery; anything that does not rule out death from cardiac causes. Non-cardiac death: defined as death from causes other than the above cardiac causes.
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Time frame: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure
The number and rate of Myocardial Infarction (MI)
Attributable to target vessel (TV-MI), Not attributable to target vessel (NTV-MI)
Time frame: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure
The number and rate of Target Lesion Revascularization (TLR)
Ischemia-driven TLR (ID-TLR), Not ischemia-driven TLR (NID-TLR)
Time frame: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure
The number and rate of Target Vessel Revascularization (TVR)
Ischemia-driven TVR (ID-TVR), Not ischemia-driven TVR (NID-TVR)
Time frame: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure
The number and rate of Any Revascularization
Ischemia-driven , Not ischemia-driven
Time frame: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure
The number and rate of Thrombosis (per ARC definition)
Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable)
Time frame: 1 month, 6 months, 9 months, 1 year and 2 years after index procedure
In-segment angiography binary restenosis (ABR, %)
Defined as the proportion of subjects with restenosis occurring in the target lesion segment and the diameter stenosis ≥50%.Quantitative coronary angiography analysis (QCA) calculation (1- 9 months after the operation of the original stent restenosis in-segment residual minimum lumen diameter / reference vessel diameter) ×100%
Time frame: 9 months after index procedure