The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Dissolve™ are to be used in the trial
SeQuent®Please are to be used in the trial
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
In-segment Late Lumen Loss
In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the device and 5 mm proximal and 5 mm distal to the device from post-procedure to 9 months by angiography.
Time frame: From the end of procedure to 9 months after the procedure
Device success rate of the interventional therapy
Successful delivery and use of the assigned balloon at the intended target lesion and successful withdrawal of the delivery system with attainment of final residual stenosis of less than 30% and TIMI 3 blood flow by visual estimation.
Time frame: From the start of index procedure to end of index procedure
Lesion success rate of the interventional therapy
Attainment of final residual stenosis of target lesion less than 30% and TIMI 3 blood flow by visual estimation.
Time frame: From the start of index procedure to end of index procedure
Clinical success rate of the interventional therapy
Achievement of final residual stenosis of less than 30% by visual estimation with successful delivery and use of assigned balloon at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat Target lesion revascularization (TLR).
Time frame: 7 days after the procedure
Rate of restenosis in the target lesions
Restenosis is defined as stenosis \> 30% by angiography
Time frame: 9 months after the procedure
TLR rate
Time frame: 9 months after the procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing Hospital
Beijing, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University People's Hospital, Capital Medical University
Beijing, China
Xiangya Hospital of Central South University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
...and 5 more locations
Target vessel revascularization (TVR) rate
Time frame: 9 months after the procedure
Target lesion failure (TLF) rate
Time frame: 9 months after the procedure
Rate of major adverse cardiovascular events
Time frame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
Rate of all adverse events and severe adverse events
Time frame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure