Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients With Coronary ISR
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT04767022
- Lead Sponsor
- Genoss Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 224
Inclusion Criteria:<br><br>Subject related inclusion criteria<br><br> - Age=18 years old & =80 years old.<br><br> - Patients with stable angina pectoris, unstable angina pectoris, stable acute<br> myocardial infarction or confirmed silent myocardial ischemia.<br><br> - Patients who can understand the purpose of the study and voluntarily participate in<br> and sign informed consent.<br><br> - It is suitable for patients undergoing percutaneous coronary intervention (PCI) or<br> coronary artery bypass grafting (CABG).<br><br>Desease related inclusion criteria<br><br> - The target lesions were in stent restenosis: Mehran type I, II and III stenosis.<br><br> - The stenosis rate of target lesion diameter was more than 70%, or more than 50%,<br> accompanied by objective evidence of ischemia (such as stress electrocardiogram,<br> myocardial perfusion imaging, FFR, etc.)<br><br> - The reference vessel diameter of the target lesion was 2.0-4.0 mm, and the target<br> lesion length was less than or equal to 26 mm.<br><br> - It is expected that no more than two drug balloons will be used in each subject, and<br> each target lesion can be covered by one drug balloon.<br><br> - At most 2 primary lesions need interventional treatment, and the distance from the<br> target lesion is more than or equal to 10 mm, and can be successfully treated before<br> the intervention of the target lesion.<br><br>Exclusion Criteria:<br><br>Subject related exclusion criteria<br><br> - A woman who is pregnant, lactating, or planning a pregnancy.<br><br> - Patients with cardiogenic shock, acute infection, known bleeding or coagulation<br> disorder, or history of cerebral hemorrhage, subarachnoid hemorrhage, active peptic<br> ulcer and gastrointestinal bleeding within 3 months before operation.<br><br> - Patients who are known to be allergic to aspirin, clopidogrel, ticagrelor, heparin,<br> contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel or<br> ticagrelor.<br><br> - Patients with acute myocardial infarction within 1 week before operation.<br><br> - Patients with Takayasu arteritis.<br><br> - Left ventricular ejection fraction = 30%.<br><br> - Acute or chronic renal insufficiency (serum creatinine > 2.0mg/dl or 178 µ mol / L).<br><br> - Patients with life expectancy less than 1 year.<br><br> - Patients participating in clinical trials of other drugs or medical devices.<br><br> - According to the researcher's judgment, the patient's clinical condition is not<br> suitable for this study, or the patient is expected to be unable to complete the<br> follow-up study according to the protocol.<br><br>Disease related exclusion criteria<br><br> - The target lesion was total occlusion (Mehran type IV).<br><br> - The target and non target lesions were left main artery lesions.<br><br> - The target lesions were ostial, pontine and bifurcated lesions with branch diameter<br> = 2.5mm.<br><br> - Three vessel disease requiring treatment.<br><br> - More than 3 lesions (including target lesions and non target lesions) need to be<br> treated in target vessels.<br><br> - ISR lesions intervened within 6 months before operation.<br><br> - Angiography confirmed thrombus in the target vessel.<br><br> - The target vessel is severely calcified, tortuous and angulated, so it is expected<br> that the drug balloon catheter will not pass successfully.<br><br> - The lesions that could not be pre dilated successfully were grade C or above<br> dissection after pre dilation, or residual stenosis > 30%, or TIMI blood flow <<br> grade III.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In-segment late lumen loss after percutaneous coronary intervention in patients with ISR
- Secondary Outcome Measures
Name Time Method