The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.
This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
230
use paclitaxel coated coronary balloon catheters to treat SVD
use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, China
RECRUITINGAngiographic percent diameter stenosis
(1-Segmental minimum lumen diameter \[MLD\]/ segmental reference vessel diameter \[RVD\]) ×100%
Time frame: at 9 months post-procedure
Acute success
Including instrument success rate, lesion success rate and surgical success rate
Time frame: in the procedure
Rate of target lesion failure
A composite of cardiac death, target-vessel related myocardial infarction, and ischemia-driven target lesion revascularization
Time frame: within 12 months post-procedure
Diameter stenosis in-device
(1-the minimum cavity diameter of the device \[MLD\] / the reference vessel diameter of the device \[RVD\]) ×100%
Time frame: at 9 months post-procedure
Late lumen loss
Loss of late lumen in the segment and device
Time frame: at 9 months post-procedure
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