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