Bioresorbable iron-covered aortic stent for coarctation of the aorta

Safety and Efficacy of Bioresorbable Iron-Based Covered Stent System for the Treatment of Coarctation of the Aorta: A Single-Center Clinical Study

This trial will try a bioresorbable iron-covered aortic stent in people aged 1–60 with coarctation of the aorta to see if it prevents restenosis over 12 months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 1 Year to 60 Years
• Sex: All
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Academic / other)
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT07316855 on ClinicalTrials.gov

What this trial studies

This is a single-center feasibility study enrolling 10 participants with native coarctation or post‑operative anastomotic stenosis who meet hemodynamic and vessel-size criteria. Each participant will receive a surgically implanted iron-based bioresorbable covered scaffold without a control group. Follow-up visits and imaging are scheduled at 1, 3, 6, and 12 months after the procedure. The primary endpoint is the rate of no restenosis at 12 months on a per‑target‑lesion basis.

Who should consider this trial

Good fit: Ideal candidates are people aged 1–60 with symptomatic coarctation of the aorta or post‑operative anastomotic stenosis who meet the pressure gradient, stenosis or Doppler velocity criteria and have a reference vessel diameter of 4–16 mm and can commit to one-year follow-up.

Not a fit: Patients outside the 1–60 year age range, with reference vessel diameters outside 4–16 mm, with life expectancy under one year, or with contraindications to the device or surgery are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the device could provide a covered stent that gradually dissolves, potentially lowering long-term complications and the need for repeat procedures.

How similar studies have performed: Bioresorbable vascular scaffolds have shown mixed results in other vascular settings, and iron-based covered aortic stents are largely novel with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc.
2. 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.
3. Patients with known allergy to contrast agent, iron and its degradation products.
4. Patients with hemorrhagic disorders
5. Patients with contraindications on antiplatelet agents and anticoagulant therapy.
6. Patients with thrombosis at the vascular wall of target lesion and the distal or proximal location of the lesion.
7. Patients with known severe renal or hepatic insufficiency, which are unsuitable for index procedure
8. Target lesion to be treated where stent was implanted previously.
9. 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.
10. Other conditions that are unfavorable for stent delivery or balloon expansion.
11. 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.
12. Patients who are not suitable for participating the trial as per investigator judgement.

Where this trial is running

Zhengzhou, Henan

• Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Taibing Fan, MD — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Shubo Song, MD

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