Safety and Efficacy of Bioresorbable Iron-Based Covered Stent System for the Treatment of Coarctation of the Aorta: A Single-Center Clinical Study
A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases
• 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