EASYII - A Post-Market Clinical Follow-up Study (PMCF) in Patients With Infrarenal Aortic Aneurysm Undergoing Endovascular Stenting With the E-tegra Stent Graft System - Imaging Cohort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- JOTEC GmbH
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Primary Safety Endpoint:
研究概览
简要总结
The objective of the study is to assess the stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time as well as to evaluate safety and clinical performance of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
详细描述
In this study, patients will be observed who are treated with an aorto-iliac bifurcated or aorto-uni-iliac configuration of the E-tegra Stent Graft System for the treatment of an infrarenal aortic or aorto-iliac aneurysm. The E-tegra Stent Graft components will be implanted at the discretion of the treating physician according to the local protocols.
EASYII is an interventional, non-randomized, post-market, multicentre study. The EASYII study is conducted to further assess, within the scope of the intended purpose, the E-tegra Stent Graft, including the study specific additional exam (visit at 6 months). The patients will undergo ECG-gated CTA scans instead of static CTA scans at pre-operative planning, prior to discharge, 30 days, 6 months, 12 months in order to assess the stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time. An additional ECG-gated CTA scan may optionally be performed at 24 months if the stent fixation (barbs) and stent graft conformability continue up to the 12 months scan.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have an
- •infrarenal aortic aneurysm with diameter ≥ 50 mm in females and ≥ 55 mm in males, or
- •infrarenal aortic aneurysm with 40-50 mm that has increased in size by ≥ 1 cm per year
- •Patient is elegible for treatment inside the instructions for use of the E-tegra Stent Graft System
- •Patient is able and willing to undergo follow-up imaging and examinations prior to discharge from the hospital, at 30 days and 6 months, 12 months, and annually thereafter until 5 years follow-up
- •Patient understands and has signed the Informed Consent Form prior to intervention
- •Patient has a life expectancy of at least 5 years
排除标准
- •Patient with severe calcification or thrombi in the proximal sealing zone
- •Patient with infectious aneurysm
- •Patient with inflammatory aneurysm
- •Patient with pseudoaneurysm
- •Patient with symptomatic aneurysm
- •Patient with ruptured or traumatic aneurysm
- •Patient with suprarenal, juxtarenal, or pararenal aneurysm
- •Patient with aortic dissection
- •Patient with a reversed conical neck that is defined as a > 3 mm distal increase over a 15 mm length
- •Patient in which the E-tegra Stent Graft System is used in combination with proximal or distal extenders of another company.
- •Patient who is planned to be treated with an adjunctive aortic bare metal stent or a fenestrated stent graft
- •Patient who is planned to be treated with a chimney / chimneys in the renal or visceral vessels
- •Patient who is planned to be treated with an iliac branch device or parallel grafts in the iliac vessels
- •Patient with genetic connective tissue disease (e.g. Marfan syndrome or Ehlers-Danlos syndrome)
- •Patient with eGFR < 45 ml/min/1.73 m2 before the intervention Patient had or planned to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the E-tegra Stent Graft System
- •Patient with other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with a limited life expectancy of less than five years (i.e. heart failure, active malignancy (progressive, stable or partial remission))
- •Patient who has been enrolled in another active clinical trial that does not allow inclusion in this trial
结局指标
主要结局
Primary Safety Endpoint:
时间窗: 30 day
Rate of 30-day mortality
Primary Imaging Endpoint:
时间窗: 30 day
Quantifying stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time at 30 day follow-up
次要结局
- Secondary limb patency(30-day, 12, 24, 36, 60 months)
- Decreasing aneurysm size(12, 60 months)
- Endoleak Type III(12, 60 months)
- Stent graft infection(30-day, 12, 24, 36, 60 months)
- Stable aneurysm size(12, 60 months)
- Reintervention(30-day, 12, 24, 36, 60 months)
- Mortality(24 hours, 12, 24, 36, 60 months)
- Technical success(24 hours)
- Clinical success(12 months)
- Stent stability and durability as well as the seal of the stent graft over time based on ECG-gated CT scans(prior to discharge, 6, 12, and optionally at 24 months follow-up)
- Reintervention-free survival(12 months)
- Primary limb patency(30-day, 12, 24, 36, 60 months)
- Dislodgement(30-day, 12, 24, 36, 60 months)
- Stent stability and durability as well as the seal of the stent graft during the cardiac cycle based on ECG-gated CT scans(prior to discharge, 6, 12, and optionally at 24 months follow-up)
- Aneurysm-related mortality(30-day, 12, 24, 36, 60 months)
- Aneurysm rupture-related mortality(30-day, 12, 24, 36, 60 months)
- Major adverse events(30-day, 12, 24, 36, 60 months)
- Endoleak Type Ia(12, 60 months)
- Endoleak Type Ib(12, 60 months)
- Stent fracture(12, 60 months)
- QoL(6, 12, 48 to 60 months)
- Increasing aneurysm size(12, 60 months)
- Endoleak Type II(12, 60 months)
- Endoleak Type IV(12, 60 months)
- Endoleak of unknown origin(12, 60 months)
- Stent graft migration(12, 60 months)
- Health status(6, 12, 48 to 60 months)