NCT06385067

Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter

Prospective, International Multicenter Clinical Study Evaluating the Safety and Efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter (BioAscend) in the Treatment of Primary Coronary Artery Disease in the Real World

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: JW Medical Systems Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world. The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.

Detailed description

Study Design: 1. Prospective, international multi-center clinical study; 2. It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions; 3. In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis. 4. Register and collect data using the EDC system; 5. Enrollment method: competitive enrollment; 6. Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Biolimus Coated Coronary Artery Balloon Dilation Catheter	Patients with Coronary Artery Disease will be treated with Biolimus Coated Coronary Artery Balloon Dilation Catheter

Timeline

• Start date: 2024-05-10
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2024-04-25
• Last updated: 2024-04-25