NL-OMON56642尚未招募不适用
Prospective, Non-Randomised Clinical Trial to investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System treating Aorto-iliac Occlusive Disease with CERAB (Covered Endovascular Reconstruction of Aortic Bifurcation) - CERAB
FCRE - Foundation for Cardiovascular Research and Education0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient has been identified with an aorto-iliac occlusive lesion, with
- •clinical necessity for treatment. 2. The patient has been diagnosed with
- •symptomatic peripheral artery disease, defined by Rutherford Becker
- •Classification score 2 to 5. 3. Patient has a projected life-expectancy of at
- •least 24 months. 4. Patient is >=18 years old. 5. Patient is willing and capable
- •to provide written consent to participate to the trial and confirmed to attend
- •the expected follow-up visits. 6. Patient*s anatomy is eligible for CERAB
- •treatment, without the need for chimneys and can be treated with a Ø 12 mm BGA.
- •7. The aorto-iliac lesion begins at least 1 cm below the patent renal arteries
- •without a need for treatment. 8. A maximum of 3 BeGraft Peripheral (Ø 7 or 8
- •mm) per limb in the external iliac artery can be used. In case a Ø 7 mm is used
- •to extent, the distal ends must be flared to Ø 8 mm to ensure proper flow. 9.
- •The target lesion has angiographic evidence of stenosis >50% or occlusion of
- •the limb. 10. Patient*s common femoral artery and deep femoral artery are
排除标准
- •1. Patient is currently participating in another investigational drug or device
- •trial that has not completed the entire follow up period. 2. Patient has
- •planned any surgical intervention/procedure within 30 days after the study
- •procedure. 3. Patient had a Myocardial infarction or stroke within a period of
- •3 months prior to the study procedure. 4. Patient had surgery (e.g. bypass
- •surgery or stenting) in target vessels previously. 5. Patient with acute aortic
- •or iliac occlusive disease. 6. Patient has an acute systemic infection at time
- •of screening or in period of 30 days prior to screening. 7. Patient has fresh
- •thrombus at time of screening or in period of 14 days prior to screening. 8.
- •Patient has a CERAB procedure that is staged. 9. Female patient with
- •childbearing potential not taking adequate contraceptives or currently
- •breastfeeding 10. Patients for whom antiplatelet therapy, anticoagulants or
- •thrombolytic drugs are contraindicated 11. Patients with known hypersensitivity
- •to the stent material (L605) and/or PTFE 12. An aneurysm in the abdominal
- •aortic and iliac segments where CERAB will be placed is present. 13. Patient
- •has access vessel that is too tortuous, narrow or any other reason that would
- •lead to failure of introducing and advancing an introducer sheath. 14. Patient
- •has or had aortic coarctation. 15. Patient had aortic injury/trauma related
- •interventions previously. 16. Patient had suprarenal/visceral segment
- •reconstructions previously. 17. A relevant accessory renal artery (>3 mm) in
- •the infrarenal aorta is present, that might be occluded during the procedure.
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