A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Arte… (NCT04973540) | Clinical Trial Compass
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A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis
China82 participantsStarted 2021-07-13
Plain-language summary
This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.
Who can participate
Age range1 Year – 14 Years
SexALL
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Inclusion criteria
✓. Patients must between 1 and 14 years old.
✓. Patients who have congenital or secondary pulmonary artery stenosis (including pulmonary artery trunk, left pulmonary artery and right pulmonary artery), and meeting one of the following criteria:
✓. Patients and whose family have high compliance, voluntarily participate in and sign the informed consent form, and complete the 2-year follow-up.
✓. Patients have life expectancy \>2 year after successful stent implantation.
Exclusion criteria
✕. Patients who have a history of disease related to 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 or the distal or proximal location.
✕. Patients with known severe renal or hepatic insufficiency which are unsuitable for index procedure as per investigator judgement.