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 range1 Year – 60 Years

SexALL

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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.
✕. Patients with known severe renal or hepatic insufficiency, which are unsuitable for index procedure
✕. Target lesion to be treated where stent was implanted previously.

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