Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) Technique for Extensive Aortoiliac Occlusive Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 53
- 主要终点
- Primary patency
研究概览
简要总结
To evaluate the safety and efficacy of the CERAB technique as an alternative to surgical reconstruction for treatment of aorto-iliac occlusive disease.
详细描述
According to the Trans-Atlantic Inter-society Consensus (TASC-II), bypass grafting is the treatment of choice for extensive aortoiliac occlusive disease (AIOD) due to the good long-term patency rates. However, surgical reconstruction is associated with peri-operative morbidity and mortality.
Kissing stent technique was introduced as an endovascular treatment alternative for bilateral aortoiliac occlusive disease in 1991. Reported technical success rates varied with the use of bare metal stents in extensive AOID.
The COBEST trial showed that covered balloon expandable stents (CBES) have a superior primary patency rate and clinical improvement outcome at 24 months when compared with bare metal stents. CBES may immediately reduce the risk of procedural complications such as dissection, perforation, in-stent stenosis, and embolization.
In 2013, CERAB technique was introduced to improve endovascular treatment results by a more anatomical and physiological reconstruction, with a subsequent better clinical outcome.
The CERAB technique was developed to overcome the anatomical and physiological disadvantages of kissing stents such as flow disturbances leading to turbulence and stasis of blood, which may cause thrombus formation and intimal neohyperplasia.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years and older patients.
- •Patient presented with disabling claudication pain.
- •Patient presented with rest pain.
- •Patient presented with gangrene or atrophic changes.
- •Provided written informed consent.
- •Eligible anatomy for CERAB technique.
- •TASC- (II) classification as assigned in the study protocol (specified type B, C and D lesions).
排除标准
- •Age less than 18 years old.
- •Patients with acute limb ischemia.
- •Patients treated with open surgery and other endovascular techniques such as kissing stenting.
- •CERAB configuration extending into aneurysmatic infrarenal aorta.
- •Patient's life expectancy <2 years as judged by the investigator.
- •Patient has a psychiatric or other condition that may interfere with the study.
- •Patient has a known allergy to any device component.
- •Patients with a systemic infection who may be at increased risk of endovascular graft infection.
- •Patient has a coagulopathy or uncontrolled bleeding disorder.
- •Patient had a recent cerebrovascular accident (CVA) or a myocardial infarction (MI) within the prior three months.
- •Patient is pregnant (Female patients of childbearing potential only).
结局指标
主要结局
Primary patency
时间窗: 12 months
uninterrupted patency in the absence of re-stenosis or occlusion, without any procedures performed on the vessel or stent.
Technical success
时间窗: 1 month
successful implantation of the CERAB device restoring blood flow with \<30% residual stenosis without conversion to open repair during the 30-days after implantation
次要结局
- Secondary patency(12 months)
- Freedom from target lesion revascularization (TLR)(12 months)
- Clinical improvement(12 months)
- Re-stenosis(12 months)
- Limb salvage rate(12 months)
- Minor complications(12 months)
研究者
Omar Mohamed Abd Elhakam Abd Elbaqi
Principal Investigator
Assiut University