NCT07316855

Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial

Safety and Efficacy of Bioresorbable Iron-Based Covered Stent System for the Treatment of Coarctation of the Aorta: A Single-Center Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shubo Song · Academic / Other
• Sex: All
• Age: 1 Year – 60 Years
• Healthy volunteers: Not accepted

Summary

A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases

Detailed description

There is a feasibility study. Ten subjects are intended to participate in this study and without control group. The Iron Bioresorbable Covered Scaffold System will be implanted surgically. Follow-up will be conducted at 1 month, 3 months, 6 months and 12 months post-procedure. The primary endpoint is the rate of no restenosis of the stent at 12 months post-procedure \[Defined on a per target lesion basis\]

Conditions

• Coarctation of the Aorta

Interventions

Type	Name	Description
DEVICE	Implantation of Bioresorbable Iron-based Covered Aortic Stent	A novel bioresorbable iron-based covered stent for coarctation of the aorta

Timeline

• Start date: 2024-08-16
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

1 site across 1 country: China