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Completed

NCT Number: NCT06012123

BS-CERAB TECHNIQUE

The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way. With the use of this technique, a covered stent is expanded 15 to 20 mm above the aortic bifurcation and this stent is proximally adapted to the aortic wall with a larger balloon, thereby creating a cone-shaped stent. Two iliac covered stents are then placed in the distal conic segment and simultaneously inflated, making a tight connection with the aortic stent, as if they were molded together, thus simulating a new bifurcation. This minimal invasive endovascular technique using covered stents, was developed in order to optimize endovascular mimicking the anatomical configuration of the aortic bifurcation and in an attempt to overcome the disadvantages of kissing stents influenced by geometric factors such as radial mismatch, protrusion mismatch and stent conformation. The use of BeGraft (balloon-expandalbe covered stent) and Solaris (self-expandable covered stent) fro this technique is revised.

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Key information

Conditions

Aortoiliac Occlusive Disease Iliac Artery Stenosis Stent Complication Vascular Device Occlusion

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Valladolid Univeristy Hospital

Valladolid, 47003, Spain

About this study

The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way.

With the use of this technique, a covered stent is expanded 15 to 20 mm above the aortic bifurcation and this stent is proximally adapted to the aortic wall with a larger balloon, thereby creating a cone-shaped stent. Two iliac covered stents are then placed in the distal conic segment and simultaneously inflated, making a tight connection with the aortic stent, as if they were molded together, thus simulating a new bifurcation.

This minimal invasive endovascular technique using covered stents, was developed in order to optimize endovascular mimicking the anatomical configuration of the aortic bifurcation and in an attempt to overcome the disadvantages of kissing stents influenced by geometric factors such as radial mismatch, protrusion mismatch and stent conformation.

The use of BeGraft (balloon-expandalbe covered stent) and Solaris (self-expandable covered stent) fro this technique is revised.

A retrospective study included patients that underwent endovascular treatment of atherosclerotic steno-occlusive aorto-iliac lesions between January 2020 and June 2023. The study, which received no financial support from industry, was performed in agreement with the Declaration of Helsinki and was approved by our institutional review boards. In accordance with institutional and local regulatory policies, this retrospective review of de-identified procedural and follow-up data was exempt from informed consent.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with lifestyle-limiting intermittent claudication, ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented steno-occlusive disease of the aortic bifurcation undergoing endovascular treatment by CERAB and PTA/covered stenting of iliac arteries

Exclusion criteria

  • Patients who could not receive antiplatelet or anticoagulation therapies.
  • Patients with concomitant aneurysm of the aorta, acute thrombus, unsalvageable limb or very limited life-expectancy.

Treatment and study plan

Aortoiliac angioplasty and stenting

Procedure

Covered endovascular reconstruction of aortic bifurcation (CERAB) in patient with aorto-iliac occlusive disease

Primary outcomes

  1. Primary patency

    Time frame: 12 months

    Absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions

Secondary outcomes

  1. Primary-assisted patency

    Time frame: 12 months

    Patent aoto-iliac segment that underwent further intervention within the inflow, treated vessel segment, or outflow of the treated vessel segment to improve patency

  2. Secondary patency

    Time frame: 12 months

    Requiring a secondary intervention to restore patency after occlusion of the treated segment. Secondary interventions include PTA, drug-eluting balloon PTA (DEB-PTA), additional stent placement or surgical bypass based on clinical deterioration.

  3. Mortality

    Time frame: 12 months

  4. Amputation rate

    Time frame: 12 months

    Major and minor amputation rate

  5. Clinical status

    Time frame: 12 months

    Rutherford scale

  6. ABI measurements

    Time frame: 12 months

    Ankle-Brachial index

Sponsors and collaborators

Lead sponsor

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Network

Registry information

Official study title

COMBINATION OF BEGRAFT AND SOLARIS STENTGRAFTS FOR THE COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (BS-CERAB) TECHNIQUE

Acronym: BS-CERAB

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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