NL-OMON55918招募中4 期
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 - EASYII
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- JOTEC GmbH
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 65 至 99（—）
入选标准
- •Inclusion Criteria:
- •* Age >= 65
- •* Patient must have an
- •o infrarenal aortic aneurysm with diameter >= 50 mm in females and >= 55 mm in
- •o infrarenal aortic aneurysm with 40-50 mm that has increased in size by >= 1 cm
- •* 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
- •Exclusion Criteria:
- •* 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
研究者
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