NCT05929313

Scoreflex TRIO - Scoring PTCA Catheter

A Prospective, Multicenter, Randomized Controlled, Non- Inferiority Trial to Evaluate the Effectiveness and Safety of the Scoreflex TRIO High-pressure Tri-wire Scoring Balloon Catheter for Balloon Dilatation of Coronary Artery Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: OrbusNeich · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.

Detailed description

This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 210 subjects. All subjects enrolled will be randomly assigned to the test group (n=105) and the control group (n=105). Subjects in the test group and the control group will receive Scoreflex TRIO Scoring PTCA catheters and Scoreflex NC Scoring PTCA catheters respectively.

Conditions

• Coronary Arteriosclerosis

Interventions

Type	Name	Description
DEVICE	OrbusNeich Scoreflex TRIO	To dilate coronary arteries during the subject's index procedure with Scoreflex TRIO Scoring PTCA catheters
DEVICE	OrbusNeich Scoreflex NC	To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters

Timeline

• Start date: 2023-04-27
• Primary completion: 2024-04-30
• Completion: 2024-05-29
• First posted: 2023-07-03
• Last updated: 2024-08-26

Locations

4 sites across 1 country: China