Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients w… (NCT04767022) | Clinical Trial Compass
CompletedNot Applicable
Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR
China224 participantsStarted 2021-01-30
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO).
The experimental group was treated with Genoss® DCB, and the control group was treated with SeQuent® Please NEO.
In this study, the end point of 9 months after procedure was used as the main endpoint to evaluate the effectiveness of Paclitaxel coated PTCA balloon catheter. The safety of the catheter was evaluated by cardiovascular adverse events.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
Subject related inclusion criteria
* Age≥18 years old \& ≤80 years old.
* Patients with stable angina pectoris, unstable angina pectoris, stable acute myocardial infarction or confirmed silent myocardial ischemia.
* Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.
* It is suitable for patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
Desease related inclusion criteria
* The target lesions were in stent restenosis: Mehran type I, II and III stenosis.
* The stenosis rate of target lesion diameter was more than 70%, or more than 50%, accompanied by objective evidence of ischemia (such as stress electrocardiogram, myocardial perfusion imaging, FFR, etc.)
* The reference vessel diameter of the target lesion was 2.0-4.0 mm, and the target lesion length was less than or equal to 26 mm.
* It is expected that no more than two drug balloons will be used in each subject, and each target lesion can be covered by one drug balloon.
* At most 2 primary lesions need interventional treatment, and the distance from the target lesion is more than or equal to 10 mm, and can be successfully treated before the intervention of the target lesion.
Exclusion Criteria:
Subject related exclusion criteria
* A woman who is pregnant, lactating, or planning a pregnancy.
* Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or his…