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NOT YET RECRUITING
NCT06024525
NA

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

Sponsor: Shanghai Shenqi Medical Technology Co., Ltd

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

236

Start Date

2024-01-01

Completion Date

2026-06-01

Last Updated

2023-09-06

Healthy Volunteers

No

Interventions

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

Locations (1)

Meizhou People's Hospital (Huangtang Hospital, Meizhou Academy of Medical Sciences)

Meizhou, Guangdong, China