Evaluation of the Safety and Performance of the BMFM® Kit (Bifurcated Multilayer Flow Modulator) for the Treatment of Abdominal Aortic Aneurysm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 7
- 主要终点
- Number of Patients With Unruptured Aneurysm
研究概览
简要总结
The study purpose is to determine the safety and efficacy of the BMFM used for the endovascular treatment of aortic aneurysm involving iliac arteries. The BMFM is an adaptation of the aortic MFM® to the aorto-iliac bifurcation anatomy. It should be noted that the aortic MFM® has CE mark approval for the aortic aneurysm treatment.
详细描述
Endovascular approaches to TAAAs have evolved during the past decade. The initial experiences with fenestrated and branched endografts have shown that total endovascular repair is effective and may reduce morbidity rates in patients with arch, thoracoabdominal and pararenal aneurysms.
The Cleveland Clinic group has recently reported on their updated clinical experience with the first 633 patients treated by fenestrated and branched endografts. Operative mortality was 1.8% for pararenal, 5.2% for types I to III, and 2.3% for type IV TAAAs .
However, 30-40% of TAAA patients remain unsuitable for EVAR due to unfavorable proximal neck anatomy. There is also an increased incidence of type I proximal endoleak when established f-EVAR guidelines are disregarded, often leading to endovascular re-intervention or surgical conversion.
Currently, the use of the bifurcated stent-graft for the infrarenal aneurysm involving iliac arteries treatment has received wide distribution. The application of endovascular technology to treat infrarenal aneurysm is now commonplace because the implantation of an infrarenal endoprosthesis is a relatively simple procedure requiring adequately long proximal seal zone, diameter measurements and accurate longitudinal device placement. However, designing and implanting a device, which will accommodate the visceral branches, is more complex.
The infrarenal with unfavorable or insufficient proximal neck as well as juxtarenal aneurysms, which involve iliac arteries, could be treated by combination of the Fenestrated Stent Graft with the Bifurcated Stent Graft.
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
- •Patients must meet ALL of the following criteria:
- •Age over 18
- •Life expectancy > 12 months
- •Aortic aneurysms involving iliac arteries
- •Healthy proximal and distal landing zone
- •Adequate arterial access
- •Healthy branches and collaterals (no stenosis or previously treated by angioplasty)
- •Informed consent understood, signed and patient agrees to all follow-up visits
排除标准
- •Patients will be excluded if ANY of the following conditions apply:
- •Aneurysm rupture, impending or contained rupture
- •Aortic dissection
- •Aortic root aneurysm
- •Pleural effusion
- •Prior all surgical procedure within 30 days unless procedure is in preparation for device implantation or planned within 30 days post stent deployment
- •Myocardial infarction or cerebral vascular accident within 6 weeks of treatment
- •Presence/suspicion of connective tissue disorders, for example, Marfan or Ehlers-Danlos etc.
- •Contraindications to the anticoagulant or/ and antiplatelet medications
- •Allergic reaction to a contrast agent
- •Patient with undergoing or planned chemotherapy
- •History of bleeding disorder (coagulopathy) or thrombophilia
- •Shaggy aorta
- •Takayasu's arteritis
- •Presence/suspicion of infection (for example: mycotic aorta)
- •The use of the MFM® with stent-grafts or previously implanted stent-grafts
- •Pregnant or breastfeeding woman
- •Patients included in another clinical study
研究组 & 干预措施
treatment
aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
干预措施: Implantation of the Bifurcated Multilayer Flow Modulator (Device)
结局指标
主要结局
Number of Patients With Unruptured Aneurysm
时间窗: 12 months
Number of patients free from aortic aneurysm rupture at the 12-month timepoint
Aneurysm-related Mortality
时间窗: At 30 days, 6 and 12 months
Number of patients who had died as a consequence of their aortic aneurysm, at the 30-day, 6-month and 12-month timepoints
次要结局
- Number of Branches and Collaterals Patent(12 months)
- All Cause Mortality(30 days, 6 months and 12 months)
- Number of Patients With Major Adverse Events(12 months)
- Technical Success(The technical success was evaluated immediately at the end of procedure)
- Duration of Anesthesia(At procedure completion)
- Time of Fluoroscopy Use During the Device Implantation Procedure(During the Device Implantation Procedure)
- Volume of Constrast Media Used During the Device Implantation Procedure(During the Device Implantation Procedure)
- Estimated Blood Loss During Devie Implantation Procedure(During the Device Implantation Procedure)
- Total Device(s) Deployment Time(At procedure completion)
- Hospital Stay Duration(At hospital discharge)