Minima Stent System Post- Approval Study (PAS)

Официальное название

Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children

Обзор

This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.

Подробное описание

A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.

Вмешательства

• Устройство Minima Stent System
  Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5kg in weight.

Первичные конечные точки

• Rate of Acute Device Success [Срок оценки: End of Procedure (Following Implantation of the Stent)]
• Rate of Participants with Freedom from procedure- or device-related SAEs [Срок оценки: Immediately after Postoperative]

Вторичные конечные точки (2)

• Rate of Successful Stent Re-Dilation and Peak-to-Peak Pressure gradient [Срок оценки: During and end of procedure]
• Rate of Participants with Freedom from Stent Migration/Embolization, procedure- or device- related SAEs, and non-elective stent explant [Срок оценки: During and at end of procedure]

Критерии участия

Критерии включения

• The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent
• Indicated for treatment with the Minima Stent System per the IFU.

Критерии исключения

• Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation
• History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation
• Aortic or pulmonary artery aneurysm in the location targeted for treatment
• Body weight < 1.5 kg
• Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent
• Target vessels larger or smaller than the Minima System balloon size ranges
• Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc
• Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.
• Currently participating in an investigational drug study or another device study
• Major or progressive non-cardiac disease resulting in a life expectancy of less than six months
• Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
• Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately premedicated

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 15 центров

• Children's Hospital Los Angeles — Los Angeles
• Children's Hospital Colorado — Aurora
• Nicklaus Children's Hospital — Miami
• Children's Healthcare of Atlanta — Atlanta
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• Riley Hospital for Children at Indiana University Health — Indianapolis
• Boston Children's Hospital — Boston
• Washington University — Saint Louis
• … и ещё 7 центров

Идентификаторы

NCT: NCT06828770 · PTC-0038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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