Overview
A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases
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 \[Defined on a per target lesion basis\]
Eligibility
Inclusion Criteria:
- 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
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.
- 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.