RecruitingNot Applicable

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

China10 participantsStarted 2024-08-16

Plain-language 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

Who can participate

Age range

1 Year – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient must between 1 and 60 years old
. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1.Rate of no stent restenosis[Defined on a per target lesion basis]

Timeframe: at 12 months post-procedure

2.Acute Procedure Success

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

Trial details

NCT IDNCT07316855

SponsorShubo Song

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Shubo Song, MD

13523535453 songshubo9195@163.com

View on ClinicalTrials.gov More Coarctation of the Aorta trials