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

NCT03767686 | Terminated

• 1 other identifier: CERAB trial
• Study Type: observational
• Target: 28
• Locations: 5 countries
• Sites: 8

Brief Summary

Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease (AOID), also in extensive pathology. This is related to its minimally invasiveness, decreasing the procedural morbidity rate. When the aortic bifurcation was involved in the lesion, the patency rates of kissing stents configurations were often inferior to open repair. In 2013 the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was introduced in an attempt to improve endovascular treatment results by a more anatomical and physiological reconstruction, with a subsequent improved clinical outcome. This investigator-initiated multicenter trial will prospectively record all data on performed CERAB procedures using the Bentley balloon expandable covered stents (BeGraft Aortic and BeGraft Peripheral) in multiple International sites, in order to gain more robust real-world data on the efficacy of these stent grafts for this indication. Consecutive patients in whom a CERAB will be performed with these particular covered stents in the participating centers. Main study parameters/endpoints: The primary end-point of this study is technical success. Patency rates, peri-procedural morbidity, clinical improvement, quality of life, clinically-driven target vessel revascularization and reintervention-rate will be secondary outcome measures. Overall, patients will be followed for 5 years

Conditions

Aorto-Iliac Atherosclerosis; Aortoiliac Obstruction

Outcome Measures

Primary Outcomes (3)

• Technical success

  Technical success is defined as successful implantation of the CERAB device without occlusion during the first 30-days after implantation

  Up to 30 days

• Primary patency

  Primary patency at 12 months measured by duplex ultrasound

  Up to 12 months

• Technical success

  Technical success is defined as successful implantation of the CERAB device without conversion to open repair

  Up to 30 days

Secondary Outcomes (17)

• Technical success

  Up to 5 years of follow-up

• Technical success

  Up to 5 years of follow-up

• Technical success

  Up to 5 years of follow-up

• Clinical success

  Up to 5 years of follow-up

• Clinical success

  Up to 30 days of follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include 145 patients in whom a CERAB will be performed.

You may qualify if:

• Age 18 years or older
• Provided written informed consent
• Clinical necessity for treatment
• Eligible anatomy for CERAB without the need for chimney's
• TASC-2 classification as assigned in the study protocol (specified type B, C and D lesions)

You may not qualify if:

• Patient is participating in another conflicting clinical study
• 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 CVA or an MI within the prior three months
• Patient is pregnant (Female patients of childbearing potential only)

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (8)

Dandenong Hospital

Victoria Point, Australia

Location

A.O.U. Città della Salute e della Scienza di Torino

Torino, Italy

Location

Spanish Hospital

Mexico City, Mexico

Location

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Location

Dijklander Ziekenhuis

Hoorn, Netherlands

Location

Medical University Center Maastricht

Maastricht, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Leriche Syndrome

Condition Hierarchy (Ancestors)

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases

Study Officials

• Michel Reijnen, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 7, 2018
• Study Start: March 23, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

ME (1); NL (3); NZ (2); AU (1); IT (1)