GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- Number of Participants Demonstrating Clinical Success at 6 Months
研究概览
简要总结
The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject's legally authorized representative has been informed of the nature of the clinical investigation, agrees to its provisions, and has provided written informed consent
- •Requiring treatment* of:
- •native, acquired, or recurrent aortic coarctation, or
- •native, acquired, or recurrent pulmonary artery stenosis *As defined by the patient's medical team
- •Patency of at least one femoral vein, femoral artery, jugular vein or both carotid arteries able to accommodate the delivery system
- •Adjacent vessel to stenosis measuring > or equal to 4 mm
排除标准
- •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 pre-medicated
结局指标
主要结局
Number of Participants Demonstrating Clinical Success at 6 Months
时间窗: Through 6-month follow-up Visit
The primary efficacy endpoint will be assessed as the rate of clinical success, with the performance goal defined as a clinical success rate of greater than 77%. Clinical success is defined as: * Stenosis relief, defined by stent outer diameter ≥ 75% of the surrounding vessel immediately after deployment. * Freedom from open surgical intervention required to treat Minima Stent disfunction through 6 months. * Maintenance of stented vessel diameter ≥ 50% of post-implant diameter at 6 months; as measured using CT angiography and/or angiography.
Number of Participants With Freedom From Serious Adverse Events at 6 Months
时间窗: Through 6-month follow-up Visit
The primary safety endpoint will be assessed as the percentage of cases with freedom from procedure- or device-related SAEs resulting in an event listed below, with the performance goal defined as greater than 78% of cases: * Death * Cardiac arrest and/or emergency ECMO cannulation * Stroke * Limb loss * Vessel dissection of target lesion * Device thrombosis/occlusion * Cardiac perforation requiring percutaneous or open surgical intervention * Persistent cardiac arrhythmia requiring a pacemaker
次要结局
- Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg(immediately after deployment)
- Successful Stent Re-dilation at Re-catheterization(Immediately after re-dilation)
- Number of Patients With Freedom From Stent Embolization or Migration at 6 Months(6 months)
- Number of Patients With Freedom From Stent Fracture at 6 Months(6 months)
- Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation(90 days post re-dilation)
- Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation(Immediately after re-dilation)