Implantation of Bioresorbable Iron-based Covered Aortic Stent
Implantation of Bioresorbable Iron-based Covered Aortic Stent: A novel bioresorbable iron-based covered stent for coarctation of the aorta
Study 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
Sex
ALL
Min age
1 Year
Max age
60 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
1.Rate of no stent restenosis[Defined on a per target lesion basis] — at 12 months post-procedure Definition of stent restenosis: If the pressure difference within the stent on transthoracic echocardiography is 50% higher than the result of transthoracic echocardiography at 0-1 days post-procedure, will be considered as suspected restenosis.
2.Acute Procedure Success — after the stent is delivered to the target lesion site and expanded during the procedure Definition of Acute Procedure Success：Meeting any one of the following standards after the stent is delivered to the target lesion site and expanded during the procedure A.The pressure difference between the proximal and distal ends of the stenosis decreased by≥50% ,detected by right heart catheterization after the stent being placed.
B.The inner diameter of the original stenotic segment of the blood vessel increases by ≥50% after the stent is placed，detected by pulmonary artery angiography after the stent being placed.
Trial sites (1)
Facility
City
Region
Status
Fuwai Central China Cardiovascular Hospital
Zhengzhou
Henan
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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