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

Официальное название

Safety and Efficacy of Bioresorbable Iron-Based Covered Stent System for the Treatment of Coarctation of the Aorta: A Single-Center Clinical Study

Обзор

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

Подробное описание

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 \[Defined on a per target lesion basis\]

Вмешательства

• Устройство Implantation of Bioresorbable Iron-based Covered Aortic Stent
  A novel bioresorbable iron-based covered stent for coarctation of the aorta

Первичные конечные точки

• 1.Rate of no stent restenosis[Defined on a per target lesion basis] [Срок оценки: at 12 months post-procedure]
• 2.Acute Procedure Success [Срок оценки: after the stent is delivered to the target lesion site and expanded during the procedure]

Вторичные конечные точки (8)

• 1.Acute Technical Success [Срок оценки: after the stent is delivered to the target lesion site and expanded during the procedure]
• 2.Rate of no stent restenosis [Срок оценки: at 1,3, 6 months post-index procedure]
• 3.The rate of device related Major Adverse Events ( MAE ) and Serious Adverse Events（SAE） [Срок оценки: at 1,3, 6, 12months post-index procedure]
• 4.The rate of unexpected secondary surgical or interventional procedures [Срок оценки: at 1,3, 6, 12months post-index procedure]
• 5.Rate of Stent Thrombosis [Срок оценки: at 1,3, 6, 12months post-index procedure]
• 6.Rate of all-cause mortality [Срок оценки: at 1,3, 6, 12months post-index procedure]
• 7.The rate of displacement after stent implantation [Срок оценки: at 1,3, 6, 12months post-index procedure]
• 8.The rate of Major Adverse Events ( MAE ) and Serious Adverse Events（SAE）during the study [Срок оценки: at 1,3, 6, 12months post-index procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Китай · 1 центр

• Fuwai Central China Cardiovascular Hospital — Чжэнчжоу

Идентификаторы

NCT: NCT07316855 · CoA-ICS-I · 251111314300

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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