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

NCT ID: NCT07316855

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

TBSI-CoA

Transcatheter bioresorbable iron-based covered stent implantation for the patients with coarctation of the aorta

Group Type: EXPERIMENTAL

Implantation of Bioresorbable Iron-based Covered Aortic Stent

Intervention Type: DEVICE

A novel bioresorbable iron-based covered stent for coarctation of the aorta

Interventions

Implantation of Bioresorbable Iron-based Covered Aortic Stent

A novel bioresorbable iron-based covered stent for coarctation of the aorta

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central China Fuwai Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Shubo Song

OTHER

Sponsor Role: lead

Responsible Party

Shubo Song

Associate Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Taibing Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shubo Song, MD

Role: CONTACT

songshubo9195@163.com

13523535453

Facility Contacts

Shubo Song, MD

Role: primary

songshubo2008@126.com

123456

Other Identifiers

251111314300

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CoA-ICS-I

Identifier Type: -

Identifier Source: org_study_id