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

NCT07290101 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Iliac Artery Stenosis
  • Iliac Artery Occlusion

Interventions

DEVICE

Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System

Subjects in the arm will be treated with ICS-Elpis

Sponsors & Collaborators

  • Biotyx Medical (Shenzhen) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2027-12-01
Completion
2028-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290101 on ClinicalTrials.gov