Status:
TERMINATED
Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease
Lead Sponsor:
Rijnstate Hospital
Conditions:
Aorto-Iliac Atherosclerosis
Aortoiliac Obstruction
Eligibility:
All Genders
18+ years
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 mo...
Detailed Description
Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease (AOID) also for complex lesions. This is related to the minimally invasiveness of the procedure decreasing the m...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
March 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03767686
Start Date
March 23 2019
End Date
March 30 2020
Last Update
April 1 2020
Active Locations (8)
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1
Dandenong Hospital
Victoria Point, Australia
2
A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy
3
Spanish Hospital
Mexico City, Mexico
4
Rijnstate Hospital
Arnhem, Gelderland, Netherlands