Coronary Artery Disease Clinical Trial
Official title:
Prospective, Multi-center Non-inferiority and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®
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. ;
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