Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial (CoA-ICS-I)

Shubo Song

Status: Enrolling

Conditions: Coarctation of the Aorta

Treatments: Device: Implantation of Bioresorbable Iron-based Covered Aortic Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT07316855

251111314300 (Other Grant/Funding Number)

CoA-ICS-I

Details and patient eligibility

About

A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases

Full 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]

Enrollment: 10 estimated patients

Sex: All

Ages: 1 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

TBSI-CoA

Experimental group

Description:

Transcatheter bioresorbable iron-based covered stent implantation for the patients with coarctation of the aorta

Treatment:

Device: Implantation of Bioresorbable Iron-based Covered Aortic Stent