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

NCT07316855 | Recruiting DMC

• 2 other identifiers: CoA-ICS-I251111314300
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Coarctation of the Aorta

Keywords

Coarctation of the Aorta; Bioresorbable; covered stent; Biodegradable; iron-based

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 1.Acute Technical Success

  after the stent is delivered to the target lesion site and expanded during the procedure

• 2.Rate of 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）

  at 1,3, 6, 12months post-index procedure

• 4.The rate of unexpected secondary surgical or interventional procedures

  at 1,3, 6, 12months post-index procedure

• 5.Rate of Stent Thrombosis

  at 1,3, 6, 12months post-index procedure

Study Arms (1)

TBSI-CoA

EXPERIMENTAL

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

Device: Implantation of Bioresorbable Iron-based Covered Aortic Stent

Interventions

Implantation of Bioresorbable Iron-based Covered Aortic Stent DEVICE

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

TBSI-CoA

Eligibility Criteria

• Age: 1 Year - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• The patients and their families have high compliance, sign the informed consent and willing to undergo 1-year follow-ups and related examinations.
• The patient's expected lifespan is more than one year after successful treatment with the stent.
• Reference vessel (diameter of the adjacent normal segment vessel ) diameter：4-16mm

You may not qualify if:

• Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc.
• 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.
• Patients with known allergy to contrast agent, iron and its degradation products.
• Patients with hemorrhagic disorders
• Patients with contraindications on antiplatelet agents and anticoagulant therapy.
• Patients with thrombosis at the vascular wall of target lesion and the distal or proximal location of the lesion.
• Patients with known severe renal or hepatic insufficiency, which are unsuitable for index procedure
• Target lesion to be treated where stent was implanted previously.
• 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.
• Other conditions that are unfavorable for stent delivery or balloon expansion.
• 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.
• Patients who are not suitable for participating the trial as per investigator judgement.

Sponsors & Collaborators

• Shubo Song: lead
• Central China Fuwai Hospital of Zhengzhou University: collaborator

Study Sites (1)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Taibing Fan, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shubo Song, MD

CONTACT

13523535453; songshubo9195@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: single-center, single-group, target value, clinical trial

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: August 16, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Access Criteria: The International Committee of Medical Journal Editors can access the IPD

Locations

CN (1)