A European Post-Market Clinical Follow-up Study (PMCF) in Patients With Infrarenal Aortic Aneurysm Undergoing Endovascular Stenting With the E-tegra Stent Graft System
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
- 151
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The EASY post-market clinical follow-up study is undertaken to demonstrate 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 receive an E-tegra Stent Graft for the treatment of infrarenal aortic aneurysm. The E-tegra Stent Graft will be implanted at the discretion of the treating physician.
Participating physicians will provide their observations collected during routine care for patients they have decided to treat with the E-tegra stent graft. Informed consent of the patients to the use of their clinical records for study purposes will be obtained before their data will be collected in the post-market clinical follow-up study. All patients will be asked to complete questionaires focussing on the health status (HS) (SF-12) and Quality of Life (QoL) (WHOQOL-BREF).
The period of data collection will be approximately 60 months from the date of intervention for each patient. Source document verification will be performed on 100% of the patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans as well as other imaging files (e.g. CEUS, MRT) will be sent to a CoreLab for independent second evaluation. There is no CoreLab screening before inclusion. All adverse events defined prior to study start, will be adjudicated by the Clinical Evaluation Committee (CEC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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 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
Mortality
时间窗: 30-day
Rate of all-cause mortality
次要结局
- Endoleak Type II(12, 60 months)
- Endoleak Type III(12, 60 months)
- Aneurysm-related mortality(30-day, 12, 24, 36, 60 months)
- Technical success(24 hours)
- Endoleak Type IV(12, 60 months)
- Aneurysm rupture-related mortality(30-day, 12, 24, 36, 60 months)
- Clinical success(12 months)
- Endoleak Type Ib(12, 60 months)
- Mortality(24 hours, 12, 24, 36, 60 months)
- Reintervention(30-day, 12, 24, 36, 60 months)
- Reintervention-free survival(12 months)
- Secondary limb patency(30-day, 12, 24, 36, 60 months)
- Major adverse events(30-day, 12, 24, 36, 60 months)
- Stent graft migration(12, 60 months)
- Primary limb patency(30-day, 12, 24, 36, 60 months)
- Endoleak of unknown origin(12, 60 months)
- Dislodgement(30-day, 12, 24, 36, 60 months)
- Stable aneurysm size(12, 60 months)
- Decreasing aneurysm size(12, 60 months)
- Increasing aneurysm size(12, 60 months)
- Endoleak Type Ia(12, 60 months)
- Stent fracture(12, 60 months)
- Stent graft infection(30-day, 12, 24, 36, 60 months)
- Health status(6, 12, 48 to 60 months)
- QoL(6, 12, 48 to 60 months)