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NOT YET RECRUITING
NCT07290101
NA

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

Sponsor: Biotyx Medical (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-12-08

Completion Date

2028-03-01

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DEVICE

Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System

Subjects in the arm will be treated with ICS-Elpis

Locations (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China