Coarctation of the AortaCoA-ICS-INCT07316855
Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial
A study testing Implantation of Bioresorbable Iron-based Covered Aortic Stent in people with Coarctation of the Aorta, run by Shubo Song at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Coarctation of the Aorta
- What is being tested?
- Implantation of Bioresorbable Iron-based Covered Aortic Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450000
Shubo Song, MD, 123456, songshubo2008@126.com
About this study
Official title: 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
Read the 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
- Being tested
- Implantation of Bioresorbable Iron-based Covered Aortic Stent
- Keywords
- Coarctation of the Aorta, Bioresorbable, covered stent, Biodegradable, iron-based
- Medical subject headings
- Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of Bioresorbable Iron-based Covered Aortic StentDevice
A novel bioresorbable iron-based covered stent for coarctation of the aorta
| Study group | Role | What they receive |
|---|---|---|
| TBSI-CoA | Experimental | Transcatheter bioresorbable iron-based covered stent implantation for the patients with coarctation of the aorta Receives: Device: Implantation of Bioresorbable Iron-based Covered Aortic Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after the stent is delivered to the target lesion site and expanded during the procedure
Secondary outcomes (8)
1.Acute Technical Success
Technical Success
Measured: 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
Measured: 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）
Measured: 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)
Measured: at 1,3, 6, 12months post-index procedure
5.Rate of Stent Thrombosis
Stent Thrombosis
Measured: at 1,3, 6, 12months post-index procedure
6.Rate of all-cause mortality
all-cause mortality
Measured: at 1,3, 6, 12months post-index procedure
7.The rate of displacement after stent implantation
displacement after stent implantation
Measured: 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
Measured: at 1,3, 6, 12months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start16 Aug 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coarctation of the AortaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-center, single-group, target value, clinical trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shubo Song
- Sponsor type
- University, hospital or other
- Collaborators
- Central China Fuwai Hospital of Zhengzhou University
- Responsible party
- Sponsor-investigator, Shubo Song, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Taibing Fan, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316855
- Sponsor's protocol ID
- CoA-ICS-I
- Other IDs
- 251111314300
- Acronym
- CoA-ICS-I
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bioresorbable Iron-Based Covered Stent System for the Treatment of Coarctation of the Aorta: A Single-Center Clinical Study
- ClinicalTrials.gov ID
- NCT07316855
- Acronym / sponsor ID
- CoA-ICS-I / CoA-ICS-I
- Conditions
- Coarctation of the Aorta
- Keywords
- Coarctation of the Aorta, Bioresorbable, covered stent, Biodegradable, iron-based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shubo SongUniversity, hospital or other
- Collaborators
- Central China Fuwai Hospital of Zhengzhou University
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center, single-group, target value, clinical trial
| Arm | Type | Receives |
|---|---|---|
| TBSI-CoA | Experimental | Device: Implantation of Bioresorbable Iron-based Covered Aortic StentTranscatheter bioresorbable iron-based covered stent implantation for the patients with coarctation of the aorta |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of Bioresorbable Iron-based Covered Aortic StentA novel bioresorbable iron-based covered stent for coarctation of the aorta | Device | TBSI-CoA |
Primary outcome
1.Rate of no stent restenosis[Defined on a per target lesion basis]
Time frame: at 12 months post-procedure
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.
2.Acute Procedure Success
Time frame: after the stent is delivered to the target lesion site and expanded during the procedure
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.
8 secondary outcomes
1.Acute 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
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）
Time frame: at 1,3, 6, 12months post-index procedure
4.The rate of unexpected secondary surgical or interventional procedures
Time frame: at 1,3, 6, 12months post-index procedure
5.Rate of Stent Thrombosis
Time frame: at 1,3, 6, 12months post-index procedure
6.Rate of all-cause mortality
Time frame: at 1,3, 6, 12months post-index procedure
7.The rate of 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
Time frame: at 1,3, 6, 12months post-index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taibing Fan, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of Bioresorbable Iron-based Covered Aortic Stent in people with Coarctation of the Aorta, run by Shubo Song at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shubo Song, MD (13523535453, songshubo9195@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Rate of no stent restenosis[Defined on a per target lesion basis] (time frame: at 12 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.