BS-CERAB TECHNIQUE

NCT06012123 | Completed

• 1 other identifier: PI23-0005
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortoiliac Occlusive Disease; Stent Complication; Vascular Device Occlusion; Iliac Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Primary patency

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

  12 months

Secondary Outcomes (6)

• Primary-assisted patency

  12 months

• Secondary patency

  12 months

• Mortality

  12 months

• Amputation rate

  12 months

• Clinical status

  12 months

Interventions

Aortoiliac angioplasty and stenting PROCEDURE

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

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that underwent endovascular treatment of atherosclerotic steno-occlusive aorto-iliac lesions between January 2020 and June 2023.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery: lead

Study Sites (1)

Valladolid Univeristy Hospital

Valladolid, 47003, Spain

Location

MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: January 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 15, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)