CERAB Technique for Aortoiliac Occlusive Disease

Not Applicable

• Conditions: Aortoiliac Occlusive Disease
• Interventions: Procedure: Covered Endovacular Reconstruction of Aortic Bifurcation

• Registration Number: NCT04148456
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-13
• Study Start: 2021-01-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Age: 18 years and older patients.
2. Patient presented with disabling claudication pain.
3. Patient presented with rest pain.
4. Patient presented with gangrene or atrophic changes.
5. Provided written informed consent.
6. Eligible anatomy for CERAB technique.
7. TASC- (II) classification as assigned in the study protocol (specified type B, C and D lesions).

Exclusion Criteria

1. Age less than 18 years old.
2. Patients with acute limb ischemia.
3. Patients treated with open surgery and other endovascular techniques such as kissing stenting.
4. CERAB configuration extending into aneurysmatic infrarenal aorta.
5. Patient's life expectancy <2 years as judged by the investigator.
6. Patient has a psychiatric or other condition that may interfere with the study.
7. Patient has a known allergy to any device component.
8. Patients with a systemic infection who may be at increased risk of endovascular graft infection.
9. Patient has a coagulopathy or uncontrolled bleeding disorder.
10. Patient had a recent cerebrovascular accident (CVA) or a myocardial infarction (MI) within the prior three months.
11. Patient is pregnant (Female patients of childbearing potential only).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aortoiliac occlusive disease	Covered Endovacular Reconstruction of Aortic Bifurcation	This study will be carried out on patients with extensive Aortoiliac occlusive disease using the CERAB technique.

Primary Outcome Measures

Name	Time	Method
Primary patency	12 months	uninterrupted patency in the absence of re-stenosis or occlusion, without any procedures performed on the vessel or stent.
Technical success	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

Secondary Outcome Measures

Name	Time	Method
Secondary patency	12 months	patency achieved by all procedures aimed at recanalizing an occluded CBES, thereby preserving the endograft.
Freedom from target lesion revascularization (TLR)	12 months	an open endograft without procedures performed for re-stenosis or occlusion leading to symptoms requiring an intervention.
Clinical improvement	12 months	hemodynamic improvement with an increase of at least 0.10 in ABI, combined with a symptomatic improvement of at least one Rutherford category.
Re-stenosis	12 months	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%.
Limb salvage rate	12 months	all patients without above ankle amputations
Minor complications	12 months	those that were only temporary leading to impairment, whereas major complications were defined by permanent damage or death.