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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03767686
Registration number
NCT03767686
Ethics application status
Date submitted
3/12/2018
Date registered
7/12/2018
Date last updated
1/04/2020
Titles & IDs
Public title
Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease
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Scientific title
Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease A Multicenter, Prospective Investigator Initiated Trial
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Secondary ID [1]
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CERAB trial
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aorto-Iliac Atherosclerosis
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Aortoiliac Obstruction
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Technical success
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Assessment method [1]
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Technical success is defined as successful implantation of the CERAB device without occlusion during the first 30-days after implantation
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Timepoint [1]
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Up to 30 days
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Primary outcome [2]
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Primary patency
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Assessment method [2]
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Primary patency at 12 months measured by duplex ultrasound
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Timepoint [2]
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Up to 12 months
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Primary outcome [3]
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Technical success
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Assessment method [3]
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Technical success is defined as successful implantation of the CERAB device without conversion to open repair
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Timepoint [3]
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Up to 30 days
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Secondary outcome [1]
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Technical success
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Assessment method [1]
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Patency rates measured by duplex ultrasound
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Timepoint [1]
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Up to 5 years of follow-up
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Secondary outcome [2]
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Technical success
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Assessment method [2]
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Target vessel revascularization measured by duplex ultrasound
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Timepoint [2]
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Up to 5 years of follow-up
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Secondary outcome [3]
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Technical success
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Assessment method [3]
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Conversion to open surgery judged at every clinic visit by the investigator
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Timepoint [3]
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Up to 5 years of follow-up
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Secondary outcome [4]
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Clinical success
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Assessment method [4]
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Freedom from reinterventions judged at every clinic visit by the investigator
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Timepoint [4]
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Up to 5 years of follow-up
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Secondary outcome [5]
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Clinical success
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Assessment method [5]
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30 days morbidity judged at every clinic visit by the investigator
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Timepoint [5]
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Up to 30 days of follow-up
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Secondary outcome [6]
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Clinical success
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Assessment method [6]
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Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
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Timepoint [6]
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Up to 3 months of follow-up
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Secondary outcome [7]
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Clinical success
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Assessment method [7]
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Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
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Timepoint [7]
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Up to 6 months of follow-up
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Secondary outcome [8]
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Clinical success
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Assessment method [8]
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Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
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Timepoint [8]
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Up to 12 months of follow-up
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Secondary outcome [9]
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Clinical success
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Assessment method [9]
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Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
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Timepoint [9]
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Up to 3 months of follow-up
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Secondary outcome [10]
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Clinical success
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Assessment method [10]
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Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
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Timepoint [10]
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Up to 6 months of follow-up
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Secondary outcome [11]
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Clinical success
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Assessment method [11]
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Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
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Timepoint [11]
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Up to 12 months of follow-up
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Secondary outcome [12]
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Clinical success
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Assessment method [12]
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Overall survival investigated with every clinic visit, done by the investigator
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Timepoint [12]
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Up to 5 years of follow-up
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Secondary outcome [13]
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Clinical success
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Assessment method [13]
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Reintervention-free survival investigated with every clinic visit, done by the investigator
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Timepoint [13]
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Up to 5 years of follow-up
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Secondary outcome [14]
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Clinical success
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Assessment method [14]
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Clinical improvement as measured by the Rutherford category of which 1 is better dan 6
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Timepoint [14]
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Up to 5 years of follow-up
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Secondary outcome [15]
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Clinical success
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Assessment method [15]
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Patient reported outcomes measured by the EQ-5D questionnaire
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Timepoint [15]
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Up to 5 years of follow-up
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Secondary outcome [16]
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Clinical success
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Assessment method [16]
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Patient reported outcomes measured by the Walking Impairment Questionnaire
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Timepoint [16]
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Up to 5 years of follow-up
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Secondary outcome [17]
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Clinical success
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Assessment method [17]
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Patient reported outcomes measured by the WHOQoL Bref
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Timepoint [17]
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Up to 5 years of follow-up
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Eligibility
Key inclusion criteria
- 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/03/2020
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Sample size
Target
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Accrual to date
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Final
28
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Dandenong Hospital - Victoria Point
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Recruitment postcode(s) [1]
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- Victoria Point
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Recruitment outside Australia
Country [1]
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Italy
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State/province [1]
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Torino
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Country [2]
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Mexico
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State/province [2]
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Mexico City
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Country [3]
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Netherlands
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State/province [3]
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Gelderland
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Country [4]
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Netherlands
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State/province [4]
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Hoorn
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Country [5]
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Netherlands
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State/province [5]
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Maastricht
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Country [6]
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New Zealand
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State/province [6]
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Auckland
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Country [7]
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New Zealand
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State/province [7]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Rijnstate Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03767686
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michel Reijnen, MD, PhD
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Address
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Principal Investigator
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03767686
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