NCT05342961

Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Spinous Balloon Dilatation Catheter (Plastic-BladeTM) in the Treatment of Coronary Artery Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: CCRF Inc., Beijing, China · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd..

Detailed description

This study is a prospective, multicenter, randomized, controlled and non inferiority designed clinical trial. A total of 160 subjects with CAD from 8 centers will be randomized 1:1 to each group. All subjects evaluated the immediate lumen acquisition immediately after operation and the MACE of 30 ± 7 days after operation. The primary endpoint is the acquisition of lumen immediately after operation. The effectiveness of balloon was evaluated. The safety of balloon was evaluated by adverse events during operation.Clinical follow-up will be conducted at operation, discharge and 30 ± 7 days after operation. The target lesions included the following : opening lesions, bifurcation lesions, calcification lesions and fibrosis lesions; Diameter stenosis ≥ 70% (visual) with evidence of ischemia; Localized lesions with TIMI ≥ 1; RVD=2.00 and 4.00mm , and the vascular segment is suitable for balloon dilatation in anatomical structure。

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	spinous balloon dilatation catheter (Plastic-Blade)	To treat Coronary artery disease
PROCEDURE	spinous balloon dilatation catheter(lacrosse NSE)	To treat Coronary artery disease

Timeline

• Start date: 2022-05-16
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-04-25
• Last updated: 2022-04-25