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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease A Multicenter, Prospective Investigator Initiated Trial
Secondary ID [1] 0 0
CERAB trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aorto-Iliac Atherosclerosis 0 0
Aortoiliac Obstruction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Technical success
Timepoint [1] 0 0
Up to 30 days
Primary outcome [2] 0 0
Primary patency
Timepoint [2] 0 0
Up to 12 months
Primary outcome [3] 0 0
Technical success
Timepoint [3] 0 0
Up to 30 days
Secondary outcome [1] 0 0
Technical success
Timepoint [1] 0 0
Up to 5 years of follow-up
Secondary outcome [2] 0 0
Technical success
Timepoint [2] 0 0
Up to 5 years of follow-up
Secondary outcome [3] 0 0
Technical success
Timepoint [3] 0 0
Up to 5 years of follow-up
Secondary outcome [4] 0 0
Clinical success
Timepoint [4] 0 0
Up to 5 years of follow-up
Secondary outcome [5] 0 0
Clinical success
Timepoint [5] 0 0
Up to 30 days of follow-up
Secondary outcome [6] 0 0
Clinical success
Timepoint [6] 0 0
Up to 3 months of follow-up
Secondary outcome [7] 0 0
Clinical success
Timepoint [7] 0 0
Up to 6 months of follow-up
Secondary outcome [8] 0 0
Clinical success
Timepoint [8] 0 0
Up to 12 months of follow-up
Secondary outcome [9] 0 0
Clinical success
Timepoint [9] 0 0
Up to 3 months of follow-up
Secondary outcome [10] 0 0
Clinical success
Timepoint [10] 0 0
Up to 6 months of follow-up
Secondary outcome [11] 0 0
Clinical success
Timepoint [11] 0 0
Up to 12 months of follow-up
Secondary outcome [12] 0 0
Clinical success
Timepoint [12] 0 0
Up to 5 years of follow-up
Secondary outcome [13] 0 0
Clinical success
Timepoint [13] 0 0
Up to 5 years of follow-up
Secondary outcome [14] 0 0
Clinical success
Timepoint [14] 0 0
Up to 5 years of follow-up
Secondary outcome [15] 0 0
Clinical success
Timepoint [15] 0 0
Up to 5 years of follow-up
Secondary outcome [16] 0 0
Clinical success
Timepoint [16] 0 0
Up to 5 years of follow-up
Secondary outcome [17] 0 0
Clinical success
Timepoint [17] 0 0
Up to 5 years of follow-up

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2020
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Dandenong Hospital - Victoria Point
Recruitment postcode(s) [1] 0 0
- Victoria Point
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Torino
Country [2] 0 0
Mexico
State/province [2] 0 0
Mexico City
Country [3] 0 0
Netherlands
State/province [3] 0 0
Gelderland
Country [4] 0 0
Netherlands
State/province [4] 0 0
Hoorn
Country [5] 0 0
Netherlands
State/province [5] 0 0
Maastricht
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
New Zealand
State/province [7] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
Rijnstate Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michel Reijnen, MD, PhD
Address 0 0
Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03767686