NCT06024525

Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®

Prospective, Multi-center Non-inferiority and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Paclitaxel-Coated Coronary Balloon Catheters	to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients
DEVICE	Paclitaxel-Releasing Coronary Balloon Catheters	to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2023-09-06
• Last updated: 2023-09-06

Locations

1 site across 1 country: China