The objective of this study is to assess the safety and efficacy of the Paclitaxel-Coated Coronary Balloon Catheters Swide® (3µg/mm2 balloon surface area) in the treatment of Chinese patients with native coronary heart disease and small vessel lesions(reference diameters from 2.0mm to 2.75 mm) in comparison with Paclitaxel-Releasing Coronary Balloon Catheter SeQuent® please Neo
This study conducted a prospective, multi-center, randomized controlled, non-inferiority clinical trial to compare the safety and efficacy of the Shenqi Medical paclitaxel-coated coronary balloon catheter and the paclitaxel-eluting coronary balloon catheter (SeQuent® please Neo) in the treatment of coronary artery small vascular disease. * A total of 236 participants are planned to be recruited, and they will be allocated into the experimental group and the control group in a 1:1 ratio. * All participants will undergo clinical follow-up at 1 month, 6 months, 9 months, 1 year, and 2 years after receiving the drug-eluting balloon angioplasty procedure. * Angiographic re-evaluation will be conducted for all participants at 9 months after the procedure. The primary study endpoint will be the in-segment diameter stenosis in target lesion(%) at 9 months postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
236
to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients
to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients
Meizhou People's Hospital (Huangtang Hospital, Meizhou Academy of Medical Sciences)
Meizhou, Guangdong, China
In-segment diameter stenosis in target lesion(%).
DS% = (1 - minimum luminal diameter within the target lesion segment / reference diameter within the target lesion segment) × 100%.
Time frame: 9 months
Technical success rate
defined as the successful arrival of the device to the target lesion, successful dilation, and smooth withdrawal, without the use of any additional interventional treatment methods, with residual stenosis ≤30% (estimated method), TIMI blood flow grade 3, and no grade C or higher dissection.
Time frame: Immediate postoperative
Lesion success rate
defined as residual stenosis within the target lesion segment being ≤30% (estimated method) after using any interventional treatment method, with TIMI blood flow grade 3 and no grade C or higher dissection.
Time frame: Immediate postoperative
Procedural success rate
defined as the absence of device-related composite endpoint events during the hospitalization period on the basis of lesion success rate
Time frame: during the hospitalization and no more 7 days
The proportion of subjects with target lesion failure.
defined as the composite endpoint of cardiac death, target vessel-related myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR);
Time frame: in month-1, 6, 9, 12 ,24
The proportion of subjects with patient-related composite endpoints
defined as the composite endpoint of all-cause death, all myocardial infarctions, and any revascularization
Time frame: in month-1, 6, 9, 12 ,24
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Proportion of Subjects' mortality
Time frame: in month-1, 6, 9, 12 ,24
Proportion of Subjects' myocardial infarction
Time frame: in month-1, 6, 9, 12 ,24
Proportion of Subjects' target lesion revascularization
Time frame: in month-1, 6, 9, 12 ,24
Proportion of Subjects' any coronary revascularization
Time frame: in month-1, 6, 9, 12 ,24
Proportion of Subjects with Thrombotic Events as defined by ARC
includes definite, probable, and unexcluded thrombus in the acute, subacute, late, and late late timeframes
Time frame: in month-1, 6, 9, 12 ,24
Incidence Rate of All AE and SAE in subjects
Time frame: in month-1, 6, 9, 12 ,24
Late Lumen Loss
defined as the change in minimal lumen diameter
Time frame: 9 months
Incidence of target lesion restenosis
proportion of patients with \>50% diameter stenosis
Time frame: 9 months