NCT04148456

CERAB Technique for Aortoiliac Occlusive Disease

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortoiliac Occlusive Disease

Interventions

Type	Name	Description
PROCEDURE	Covered Endovacular Reconstruction of Aortic Bifurcation	* 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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2019-11-01
• Last updated: 2020-07-13