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Finance stop
Sponsor study identifier
observational
28
5 countries
8
Study Start
March 23, 2019
Actual (reported)Primary Completion
March 30, 2020
Actual (reported)Study Completion
March 30, 2020
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2018
Actual (reported)December 7, 2018
Actual (reported)March 23, 2019
Actual (reported)March 30, 2020
Actual (reported)March 30, 2020
Actual (reported)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
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
The study will include 145 patients in whom a CERAB will be performed.
Dandenong Hospital
Victoria Point, Australia
A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy
Spanish Hospital
Mexico City, Mexico
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Dijklander Ziekenhuis
Hoorn, Netherlands
Medical University Center Maastricht
Maastricht, Netherlands
Auckland City Hospital
Auckland, New Zealand
Michel Reijnen, MD, PhD
Principal Investigator
28 participants (actual enrollment reported by the registry).
First Submitted
December 3, 2018
First Posted
December 7, 2018
Study Start
March 23, 2019
Actual (reported)Contact the study team to confirm eligibility.
Waikato Hospital
Hamilton, New Zealand
Primary Completion
March 30, 2020
Actual (reported)Study Completion
March 30, 2020
Actual (reported)Last Updated
April 1, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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