An interventional study of Implantation of Bioresorbable Iron-based Covered Aortic Stent in Coarctation of the Aorta, sponsored by Shubo Song. Recruiting at 1 site in China. Open to participants aged 1 Year to 60 Years. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Shubo Song · Not applicable, Interventional, and Device feasibility
A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases
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]
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →This is the only study on the registry with Shubo Song as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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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)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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.
Time frame: after the stent is delivered to the target lesion site and expanded during the procedure
1.Acute Technical Success
Technical Success
Time frame: 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
Time frame: 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）
Time frame: 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)
Time frame: at 1,3, 6, 12months post-index procedure
5.Rate of Stent Thrombosis
Stent Thrombosis
Time frame: at 1,3, 6, 12months post-index procedure
6.Rate of all-cause mortality
all-cause mortality
Time frame: at 1,3, 6, 12months post-index procedure
7.The rate of displacement after stent implantation
displacement after stent implantation
Time frame: 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
Time frame: at 1,3, 6, 12months post-index procedure
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Access criteria: The International Committee of Medical Journal Editors can access the IPD
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