Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial (CoA-ICS-I)

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

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

Study Overview

• Status: Recruiting
• Conditions: Coarctation of the Aorta
• Intervention / Treatment: Device: Implantation of Bioresorbable Iron-based Covered Aortic Stent

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]

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shubo Song, MD; Phone Number: 13523535453; Email: songshubo9195@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Fuwai Central China Cardiovascular Hospital
      • Contact: Shubo Song, MD; Phone Number: 123456; Email: songshubo2008@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient must between 1 and 60 years old

   Patients being clinically diagnosed with CoA or patients with post-operative anastomotic stenosis after CoA surgery，meanwhile meeting one of the following conditions:

   A：Pressure gradient of Carctation in a calm state. B：The degree of aortic stenosis is not less than 50% (degree of Carctation Of the Arota = (diameter of adjacent normal segment of blood vessel - residual vessel lumen diameter of stenotic segment)

   • diameter of adjacent normal segment of blood vessel×100% ) C：Peak velocity of echocardiographic Doppler in the CoA≥2.5m/s
2. The patients and their families have high compliance, sign the informed consent and willing to undergo 1-year follow-ups and related examinations.
3. The patient's expected lifespan is more than one year after successful treatment with the stent.
4. Reference vessel (diameter of the adjacent normal segment vessel ) diameter：4-16mm

Exclusion Criteria:

1. Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc.
2. Patients with cardiopulmonary function that cannot tolerate surgery, such as severe heart failure (NYHA Grade III and above) that cannot be controlled by active medical treatment.
3. Patients with known allergy to contrast agent, iron and its degradation products.
4. Patients with hemorrhagic disorders
5. Patients with contraindications on antiplatelet agents and anticoagulant therapy.
6. Patients with thrombosis at the vascular wall of target lesion and the distal or proximal location of the lesion.
7. Patients with known severe renal or hepatic insufficiency, which are unsuitable for index procedure
8. Target lesion to be treated where stent was implanted previously.
9. Patients with severe stenosis or excessive tortuosity in the targeted vessel, or anatomical abnormalities, which predict the device will have difficulty reaching the target lesion.
10. Other conditions that are unfavorable for stent delivery or balloon expansion.
11. Patient who have already participated in another clinical trial, and have not yet completed or withdrawn within 3 months before the screening period of this trial.
12. Patients who are not suitable for participating the trial as per investigator judgement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TBSI-CoA; Transcatheter bioresorbable iron-based covered stent implantation for the patients with coarctation of the aorta	Device: Implantation of Bioresorbable Iron-based Covered Aortic Stent; A novel bioresorbable iron-based covered stent for coarctation of the aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1.Rate of no stent restenosis[Defined on a per target lesion basis]	Definition of stent restenosis: If the pressure difference within the stent on transthoracic echocardiography is 50% higher than the result of transthoracic echocardiography at 0-1 days post-procedure, will be considered as suspected restenosis.	at 12 months post-procedure
2.Acute Procedure Success	Definition of Acute Procedure Success：Meeting any one of the following standards after the stent is delivered to the target lesion site and expanded during the procedure A.The pressure difference between the proximal and distal ends of the stenosis decreased by≥50% ,detected by right heart catheterization after the stent being placed. B.The inner diameter of the original stenotic segment of the blood vessel increases by ≥50% after the stent is placed，detected by pulmonary artery angiography after the stent being placed.	after the stent is delivered to the target lesion site and expanded during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1.Acute Technical Success	Technical Success	after the stent is delivered to the target lesion site and expanded during the procedure
2.Rate of no stent restenosis	defined on a per target lesion basis，no stent restenosis	at 1,3, 6 months post-index procedure
3.The rate of device related Major Adverse Events ( MAE ) and Serious Adverse Events（SAE）	device related Major Adverse Events ( MAE ) and Serious Adverse Events（SAE）	at 1,3, 6, 12months post-index procedure
4.The rate of unexpected secondary surgical or interventional procedures	unexpected secondary surgical or interventional procedures (excluding the expected secondary intervention procedures)	at 1,3, 6, 12months post-index procedure
5.Rate of Stent Thrombosis	Stent Thrombosis	at 1,3, 6, 12months post-index procedure
6.Rate of all-cause mortality	all-cause mortality	at 1,3, 6, 12months post-index procedure
7.The rate of displacement after stent implantation	displacement after stent implantation	at 1,3, 6, 12months post-index procedure
8.The rate of Major Adverse Events ( MAE ) and Serious Adverse Events（SAE）during the study	Major Adverse Events ( MAE ) and Serious Adverse Events（SAE）during the study	at 1,3, 6, 12months post-index procedure

Collaborators and Investigators

• Sponsor: Shubo Song
• Collaborators: Central China Fuwai Hospital of Zhengzhou University
• Investigators: Principal Investigator: Taibing Fan, MD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Coarctation of the Aorta; Bioresorbable; covered stent; Biodegradable; iron-based
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Coarctation
• Other Study ID Numbers: CoA-ICS-I; 251111314300 (Other Grant/Funding Number: The Key Research and Development Project of Henan Province, China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The patient's age, weight, as well as the ultrasound and CT data during the perioperative period and follow-up period can be shared, but the patient's name, hospital number and ID number and other confidential information cannot be shared.
• IPD Sharing Access Criteria: The International Committee of Medical Journal Editors can access the IPD
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No