Randomized study assessing the effectiveness and safety of a novel scoring balloon for percutaneous coronary intervention: the Wedge NC trial.

ABSTRACT:

Background

Scoring balloon angioplasty catheters are designed to induce high focal stress at low inflation pressure for better lesion modification. We aimed to assess the effectiveness and safety of a newly developed Wedge NC scoring balloon catheter compared to the ScoreFlex coronary dilatation catheter for treating coronary artery lesions.

Methods

The Wedge NC trial was a prospective, multicenter, open-label, randomized controlled non-inferiority trial conducted during August 2021 and February 2022. There were 198 patients with indication for percutaneous coronary intervention (PCI) enrolled at nine centers in China. Patients undergoing angioplasty were randomly assigned to treatment with the Wedge NC scoring balloon or the ScoreFlex scoring balloon. The primary endpoint w

SUBMITTER: Chen H 

PROVIDER: S-EPMC12090169 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature