A Clinical Study to Evaluate the Effectiveness and Safety of the Allay® Aortic Stent as Adjunctive Endovascular Treatment of Type B Aortic Dissection in Patients Eligible for Thoracic Endovascular Repair With Stent Grafts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 37
- 主要终点
- Freedom from aortic growth requiring secondary reintervention, including open conversion, or aortic rupture in the region treated by the Allay® Aortic Stent at 12 months
研究概览
简要总结
This clinical trial is a prospective, multicenter, open label study designed to evaluate the effectiveness and the safety of the Allay® Aortic Stent as adjunctive endovascular treatment of Type B aortic dissection in patients eligible for thoracic endovascular aortic repair with stent grafts.
详细描述
Thoracic endovascular repair (TEVAR) with stent grafts is an established first-line treatment for acute complicated TBAD. In uncomplicated high-risk TBAD, TEVAR may be considered in selected patients based on patient characteristics, anatomy and clinical judgement, with uncertainty remaining regarding optimal patient selection, timing and long-term outcome. Although the benefits of TEVAR are well established in acute complicated TBAD, there remains significant risk of aneurysmal degeneration and late aortic complications associated with distal dissection left untreated, including aortic growth requiring reinterventions, or progression and/or rupture.
The present clinical investigation will enrol patients after the decision for proximal TEVAR has been made as per standard of care. The investigational procedure of adjunctive thoracic stent graft extension with the Allay® Aortic Stent will be performed after the placement of a CE-marked Thoracic Stent Graft in the descending thoracic aorta (proximal to the celiac trunk).
The study objective is to demonstrate that the Allay® Aortic Stent, used as adjunctive endovascular treatment of Type B aortic dissection in patients eligible for thoracic endovascular aortic repair with stent grafts, results in a low rate of aortic growth requiring secondary reintervention, including open conversion, or aortic rupture in the treated abdominal segment at 12 months. The study will also allow to evaluate the incidence of Major Adverse Events (MAE) following TEVAR, at 30 days post-implantation of the Allay® Aortic Stent.
Based on available data on similar devices, the objective performance goal is set to an expected proportion of 85% freedom from aortic growth requiring secondary reintervention or aortic rupture of the abdominal segment at 12 months.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a type B aortic dissection extending to the celiac trunk or beyond
- •Are eligible for thoracic endovascular treatment with stent grafts as per local guidelines, and physician's decision
- •Have been elected for treatment with commercially available stent graft as per their IFU within 90 days of dissection symptoms onset
排除标准
- •General Exclusion Criteria:
- •Age < 18 years
- •Pregnant, breast-feeding or planning on becoming pregnant during the entire duration of the study
- •Unable to provide written informed consent
- •Unable or unwilling to comply with the requirements of the study protocol
- •Taking part already in an investigational device or drug study that could interfere with the outcomes being studied
- •Active drug addiction or known history of drug abuse within one year of treatment
- •Medical Exclusion Criteria:
- •Aortic rupture (free or contained including haemothorax, increasing periaortic hematoma, or mediastinal hematoma)
- •Aortic fistula
- •Suspicion of bowel necrosis or irreversible visceral ischemia
- •Stage 5 chronic kidney disease
- •Life expectancy of less than 2 years due to any other medical condition than the dissection to be treated
- •Active malignancy
- •Known sensitivities or allergies to the device materials (including cobalt, chromium, nickel)
- •Known sensitivities or allergies to contrast materials that cannot be pre-medicated
- •Mycotic aortic aneurysm or active systemic infection that may place the patient at increased risk of endovascular infection
- •American Society of Anaesthesiologists (ASA) class V (moribund patient not expected to live 24 hours with or without operation)
- •Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's, Loeys-Dietz or Ehlers-Danlos syndrome)
- •Uncorrectable coagulopathy, bleeding diathesis or refusal of blood transfusion
- •Any major cardiovascular or cerebrovascular ischemic event, including myocardial infarction or stroke, or treatment of such event, within 90 days prior to enrolment
- •Any aortic-related interventional or surgical procedure within 30 days prior to enrolment
- •Any planned aortic-related interventional or surgical procedure within 30 days after the study procedure
- •Anatomical Exclusion Criteria:
- •Aneurysmal dilatation of the false lumen defined as maximum transaortic diameter >55 mm in women or >60 mm in men in the thoraco-abdominal segment or >50 mm in women or >55 mm in men in the abdominal segment, measured inner-wall to inner-wall;
- •Inadequate proximal landing zone for the stent graft, such zone being <20 mm long
- •Inadequate proximal landing zone geometry for the Allay® Aortic Stent (e.g. aortic kink)
- •Planned implantation of a stent graft with a distal diameter >38 mm or <20 mm
- •Aorta or iliac anatomy not allowing the advancement of the delivery system
- •Subject in whom the thoracic stent graft is either 1) not implanted in its intended position and/or 2) leads to any serious device complication, and/or who has 3) persistent static obstruction of the visceral or both renal arteries, prior to Allay® Aortic Stent implantation, will not be implanted with the Allay® Aortic Stent and will be withdrawn from the study
研究组 & 干预措施
Allay Aortic Stent
A covered thoracic stent graft is first deployed in supraceliac position as per standard of care then followed by the implantation of the Allay® Aortic Stent deployed from within the stent graft, extending below the celiac trunk to the end of the dissected aorta, typically the aortoiliac bifurcation.
干预措施: Allay Aortic Stent (Device)
结局指标
主要结局
Freedom from aortic growth requiring secondary reintervention, including open conversion, or aortic rupture in the region treated by the Allay® Aortic Stent at 12 months
时间窗: 12 months
An aortic growth requiring reintervention in the region treated with the Allay® Aortic Stent is defined as an increase in maximum aortic transverse diameter \>10mm at 12 months relative to the first post-operative CT scan done at discharge and not later than 30 days.
次要结局
- Percentage of Participants with Successful Technical Performance of the Allay® Aortic Stent Implantation(At index procedure)
- Incidence of Major Adverse Events (MAE) within 30 Days After Allay® Aortic Stent Implantation(30 days)
- Freedom from all-cause mortality;(Immediately at discharge and subsequent follow-up visits, at 30 days, 12, 24, 36, 48 and 60 months)
- Freedom from Dissection-Related Mortality(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from Readmission (Post-Discharge)(Subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from Aorta-Related Reintervention(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from Open Conversion(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from New Ischemia(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from Reintervention Related to Side Branches(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Aortic rupture(Assessed at discharge or not later than 30 days from index procedure, and then compared to pre-operative CT scan)
- Percentage of Participants with Patent Major Aortic Branches Post-Allay® Aortic Stent Implantation(Assessed at discharge (or within 30 days from the index procedure) and compared to the pre-operative CT scan.)
- Percentage of Participants with Patent Major Descending Aortic Branches Covered by the Allay® Aortic Stent(Assessed at discharge (or within 30 days from the index procedure) and compared to the pre-operative CT scan.)
- Percentage of Participants with Device Deficiencies Detected by CT Imaging Post-Allay® Aortic Stent Implantation(Assessed at discharge (or within 30 days from the index procedure) and compared to the pre-operative CT scan.)
- Aortic growth(Assessed at 12, 24, 36, 48 and 60 months, then compared to first post-operative CT scan done at discharge and not later than 30 days from index procedure)
- Aortic Rupture(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan done at discharge.)
- New Dissection or Extension of Dissection(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Fistula Formation Detected on Follow-Up CT Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Change in True Lumen, False Lumen, and Transaortic Diameters(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Maintained Patency in Major Aortic Branches on Follow-Up Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Maintained Patency in Major Descending Aortic Branches Covered by the Allay® Aortic Stent on Follow-Up Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Maintained False Lumen Perfusion and Patency in All Treated Segments on Follow-Up Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Device Deficiencies on Follow-Up Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)