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Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR

Genoss Co., Ltd. · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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coronary-artery-diseasena
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.
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