NCT07290101

A First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of ICS-Elpis in Patients With Iliac Artery Stenosis or Occlusion Lesions

A Prospective, Single-Center, First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System in Patients With Iliac Artery Stenosis or Occlusion Lesions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Biotyx Medical (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This trial is a prospective, single-center, first-in-man clinical trial to evaluate the feasibility, preliminary safety and effectiveness of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System. 15 subjects are intended to be enrolled.

Detailed description

Clinical follow-up visits should be conducted at before discharge, 30 days, 6 month, 9 months, and 12 months post-procedure. CTA and DUS will be performed at 6 month and 12 months post-procedure. The primary endpoints include primary patency rate of the target lesion at 12 months post-procedure and Major Adverse Events (MAE) at 9 months post-procedure.

Conditions

• Iliac Artery Stenosis
• Iliac Artery Occlusion

Interventions

Type	Name	Description
DEVICE	Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System	Subjects in the arm will be treated with ICS-Elpis

Timeline

• Start date: 2025-12-08
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: China