CERAB Technique for Aortoiliac Occlusive Disease

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of the CERAB technique as an alternative to surgical reconstruction for treatment of aorto-iliac occlusive disease.

Detailed Description
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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. The early results of the CERAB configuration are promising at 1-year follow up in a group of 130 patients with AOID and the 30-day major complication rate was 7.7%. CERAB and Chimney CERAB (C-CERAB) techniques may change the treatment algorithm of AIOD and juxta-renal occlusive disease. It appears to be a safe and feasible alternative with promising results, being a valid alternative for surgery and/or kissing stents.

Official Title
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Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) Technique for Extensive Aortoiliac Occlusive Disease

Conditions
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Aortoiliac Occlusive Disease

Intervention / Treatment
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* Procedure: Covered Endovacular Reconstruction of Aortic Bifurcation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aortoiliac occlusive disease<br>This study will be carried out on patients with extensive Aortoiliac occlusive disease using the CERAB technique. | Procedure: Covered Endovacular Reconstruction of Aortic Bifurcation<br>* The occlusive lesion is then passed, either subintimal or endoluminal, using crossing wires and catheters. After gaining re-entry into the lumen of the aorta, angiography will be confirmed proper positioning for those with a subintimal passage. A 10-12 mm V12 LD balloon expandable ePTFE covered stent (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be expanded in the distal aorta approximately 20 mm above the bifurcation through the 9 Fr sheath. The proximal 2/3 part of the aortic stent will be flared with a larger balloon, usually 16 mm, thereby creating a funnel shaped covered stent. Subsequently, two 8 mm V12 balloon expandable ePTFE covered stents (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be placed proximally in the distal 1/3 of the aortic stent, and then simultaneously deployed distally into the common iliac arteries creating a tight connection with the first aortic stent, thereby creating the new aortic bifurcation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | uninterrupted patency in the absence of re-stenosis or occlusion, without any procedures performed on the vessel or stent. | 12 months | 
| Technical success | successful implantation of the CERAB device restoring blood flow with <30% residual stenosis without conversion to open repair during the 30-days after implantation | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary patency | patency achieved by all procedures aimed at recanalizing an occluded CBES, thereby preserving the endograft. | 12 months | 
| Freedom from target lesion revascularization (TLR) | an open endograft without procedures performed for re-stenosis or occlusion leading to symptoms requiring an intervention. | 12 months | 
| Clinical improvement | hemodynamic improvement with an increase of at least 0.10 in ABI, combined with a symptomatic improvement of at least one Rutherford category. | 12 months | 
| Re-stenosis | a lesion with a peak systolic value (PSV) ratio >2.5 as measured in the endograft and proximal or distal to the endograft or an angiographic diameter reduction of >50%. | 12 months | 
| Limb salvage rate | all patients without above ankle amputations | 12 months | 
| Minor complications | those that were only temporary leading to impairment, whereas major complications were defined by permanent damage or death. | 12 months |