The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
The investigation is a prospective, multi-center, randomized control, non-inferiority clinical study. The study will be conducted in up to 8 investigational sites in the China This study will enroll and treat 136 subjects, including in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA. After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where eligibility criteria will be assessed. Then, subjects will be randomized to either trial balloon (Sino Medical Sciences Technology Inc. ) or to a NSE Coronary Dilatation Catheter (Goodman Co.,Ltd). Angiograms will be performed before and after intervention. Subjects will be followed through hospital discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Kaifeng Central Hospital
Kaifeng, China
The First People's Hospital of Lianyungang
Lianyungang, China
Rate of Device procedural success (lesion level)
Defined as: Successful delivery, inflation, deflation, and withdrawal of the study balloon; and ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis\<50%)
Time frame: immediate post-intervention(approximately 1.4 hour)
Rate of Procedural success (patient level)
Defined as: ≤30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis\<50%); and freedom from major adverse cardiac events (MACE) during hospitalization
Time frame: during the hospital stay, an average of 7 days post-procedure
Rate of Target lesion failure (TLF)
a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR)
Time frame: during the hospital stay, an average of 7 days post-procedure
Rate of Patient-oriented composite endpoint (POCE)
a composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization
Time frame: during the hospital stay, an average of 7 days post-procedure
Incidence of any AE and SAE incidence
report any AE results from a device deficiency or other device issue as related to the use of the study device. Such as Balloon burst、vascular perforation, dissection, acute occlusion, vasospasm, thrombosis (including stent thrombosis), arrhythmia requiring intervention, and so on.
Time frame: during the hospital stay, an average of 7 days post-procedure
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Tianjin Chest Hospital
Tianjin, China
Tianjin Forth Central Hospital
Tianjin, China
Wuxi People's Hospital
Wuxi, China
Xuzhou cancer hospital
Xuzhou, China
Rate of device defect
report any device defect during hospitalization
Time frame: during the hospital stay, an average of 7 days post-procedure