This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects.
This is a prospective, multicenter, randomized (1:1) controlled clinical trial, which plans to enroll 260 subjects. The aim of study is to assess the safety and efficacy of SeQuent® SCB in the treatment of in-stent restenosis in coronary arteries. All eligible subjects with ISR lesion in coronary will be randomly assigned to receive SeQuent® SCB (study group) or receive SeQuent® Please Neo (control group) balloon treatment. All subjects will be scheduled to clinical follow up at 30 days, 6 months, 9 months and 12 months after index procedure and will be scheduled to receive the angiography at 9 months after index procedure. The primary endpoint was segment late luminal loss at 9 months after index procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
260
All eligible subjects will be assigned randomly to study group or control group, receive PTCA.
Anhui Provincal Hospital
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
In-segment late loss
In-segment late loss(LLL) is defined as the difference between the MLD immediately after the procedure and the MLD at 9-month follow-up angiography after index procedure. MLDs are measured by QCA.
Time frame: at 9 months after index procedure
The success rate of intervention treatment
including device success, lesion success and clinical success
Time frame: 1-3 days
Binary restenosis rate of target lesion
A diameter stenosis of \> 50% at the previously treated lesion site, including the originally treated site plus the adjacent vascular segments 5 mm , proximal and 5 mm distal to the site . Percent diameter stenosis was defined as \[1(MLD/reference vessel diameter)\]100.
Time frame: 9 months after index procedure
Target lesion failure (TLF) rate
The composite of ischemia-driven revascularization of the target lesion, MI related to the target vessel, or cardiac death related to the target vessel
Time frame: 30 days, 6 months, 9 moths, 12 months after index procedure
PoCE
a composite of all death, MI and any revascularization
Time frame: 30 days, 6 months, 9 moths, 12 months after index procedure
ARC-defined stent thrombosis
timing (acute, subacute, late and very late stent thrombosis); relationship (definite, probable and possible stent thrombosis)
Time frame: 30 days, 6 months, 9 moths, 12 months after index procedure
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Meizhou People's Hospital
Meizhou, Guangdong, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
...and 6 more locations