Aorto-Iliac AtherosclerosisNCT03767686
Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease
An observational study of Aorto-Iliac Atherosclerosis and Aortoiliac Obstruction, run by Rijnstate Hospital at 8 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorto-Iliac Atherosclerosis, Aortoiliac Obstruction
- How many people
- 28 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 23 Mar 2019to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include 145 patients in whom a CERAB will be performed.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Netherlands3 sites
Rijnstate Hospital
Arnhem, Gelderland
Dijklander Ziekenhuis
Hoorn
Medical University Center Maastricht
Maastricht
New Zealand2 sites
Auckland City Hospital
Auckland
Waikato Hospital
Hamilton
About this study
Official title: Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease A Multicenter, Prospective Investigator Initiated Trial
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.
Read more
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
Read the 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 morbidity rate. Patency results of endovascular treatment were often inferior compared to open repair when the aortic bifurcation was involved in the lesion. In 2013 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 better clinical outcome. The early results of the CERAB configuration are promising with primary, primary-assisted and secondary patency of, respectively 86.2%/91.1%/97.0% at 1-year, 83.9%/88.7%/97.0% at 2-year and 82.1%/86.8%/97.0% at 3-year FU in a group of 130 patients, including the first in man results. The vast majority (89.2%) were TASC-II D lesions and the 30-day major complication rate was 7.7%.
This trial is designed to prospectively collect all data on implanted CERAB configurations, using the balloon expandable stents from Bentley InnoMed, in a defined group of aorto-iliac pathology in multiple international sites in order to gain more insight in the outcome of the technique. Technical success will be the primary endpoint. Other evaluations will include patency rates, quality of life, the reintervention-rate, 30-day morbidity and target vessel revascularization up to 5 years after treatment.
A total of 145 patients will be included and followed until 5 years of follow-up. A core lab will independently analyze the images (CT scan or duplex) which will be made at the following time points: pre-op, 1 month, 6 months, 1 year and yearly up to 5 years of follow-up.
Additionally, at these time points three questionnaires will be completed by the patients. These questionnaires are about walking ability (WIQ), and quality of life (EQ-5D and WHOQoL-BREF).
- Medical subject headings
- Leriche Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Technical success is defined as successful implantation of the CERAB device without occlusion during the first 30-days after implantation
Measured: Up to 30 days
Primary patency
Primary patency at 12 months measured by duplex ultrasound
Measured: Up to 12 months
Technical success
Technical success is defined as successful implantation of the CERAB device without conversion to open repair
Measured: Up to 30 days
Secondary outcomes (17)
Technical success
Patency rates measured by duplex ultrasound
Measured: Up to 5 years of follow-up
Technical success
Target vessel revascularization measured by duplex ultrasound
Measured: Up to 5 years of follow-up
Technical success
Conversion to open surgery judged at every clinic visit by the investigator
Measured: Up to 5 years of follow-up
Clinical success
Freedom from reinterventions judged at every clinic visit by the investigator
Measured: Up to 5 years of follow-up
Clinical success
30 days morbidity judged at every clinic visit by the investigator
Measured: Up to 30 days of follow-up
Clinical success
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
Measured: Up to 3 months of follow-up
Clinical success
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
Measured: Up to 6 months of follow-up
Clinical success
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
Measured: Up to 12 months of follow-up
Clinical success
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
Measured: Up to 3 months of follow-up
Clinical success
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
Measured: Up to 6 months of follow-up
Clinical success
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
Measured: Up to 12 months of follow-up
Clinical success
Overall survival investigated with every clinic visit, done by the investigator
Measured: Up to 5 years of follow-up
Clinical success
Reintervention-free survival investigated with every clinic visit, done by the investigator
Measured: Up to 5 years of follow-up
Clinical success
Clinical improvement as measured by the Rutherford category of which 1 is better dan 6
Measured: Up to 5 years of follow-up
Clinical success
Patient reported outcomes measured by the EQ-5D questionnaire
Measured: Up to 5 years of follow-up
Clinical success
Patient reported outcomes measured by the Walking Impairment Questionnaire
Measured: Up to 5 years of follow-up
Clinical success
Patient reported outcomes measured by the WHOQoL Bref
Measured: Up to 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start23 Mar 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Why it stopped: Finance stop
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorto-Iliac AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- Michel Reijnen, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767686
- Sponsor's protocol ID
- CERAB trial
- Status last verified
- Mar 2020
- First submitted
- 3 Dec 2018
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease A Multicenter, Prospective Investigator Initiated Trial
- ClinicalTrials.gov ID
- NCT03767686
- Acronym / sponsor ID
- CERAB trial
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Finance stop
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 23 Mar 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 morbidity rate. Patency results of endovascular treatment were often inferior compared to open repair when the aortic bifurcation was involved in the lesion. In 2013 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 better clinical outcome. The early results of the CERAB configuration are promising with primary, primary-assisted and secondary patency of, respectively 86.2%/91.1%/97.0% at 1-year, 83.9%/88.7%/97.0% at 2-year and 82.1%/86.8%/97.0% at 3-year FU in a group of 130 patients, including the first in man results. The vast majority (89.2%) were TASC-II D lesions and the 30-day major complication rate was 7.7%.
This trial is designed to prospectively collect all data on implanted CERAB configurations, using the balloon expandable stents from Bentley InnoMed, in a defined group of aorto-iliac pathology in multiple international sites in order to gain more insight in the outcome of the technique. Technical success will be the primary endpoint. Other evaluations will include patency rates, quality of life, the reintervention-rate, 30-day morbidity and target vessel revascularization up to 5 years after treatment.
A total of 145 patients will be included and followed until 5 years of follow-up. A core lab will independently analyze the images (CT scan or duplex) which will be made at the following time points: pre-op, 1 month, 6 months, 1 year and yearly up to 5 years of follow-up.
Additionally, at these time points three questionnaires will be completed by the patients. These questionnaires are about walking ability (WIQ), and quality of life (EQ-5D and WHOQoL-BREF).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 145 patients in whom a CERAB will be performed.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical success
Time frame: Up to 30 days
Technical success is defined as successful implantation of the CERAB device without occlusion during the first 30-days after implantation
Primary patency
Time frame: Up to 12 months
Primary patency at 12 months measured by duplex ultrasound
Technical success
Time frame: Up to 30 days
Technical success is defined as successful implantation of the CERAB device without conversion to open repair
17 secondary outcomes
Technical success
Time frame: Up to 5 years of follow-up
Technical success
Time frame: Up to 5 years of follow-up
Technical success
Time frame: Up to 5 years of follow-up
Clinical success
Time frame: Up to 5 years of follow-up
Clinical success
Time frame: Up to 30 days of follow-up
Clinical success
Time frame: Up to 3 months of follow-up
Clinical success
Time frame: Up to 6 months of follow-up
Clinical success
Time frame: Up to 12 months of follow-up
Clinical success
Time frame: Up to 3 months of follow-up
Clinical success
Time frame: Up to 6 months of follow-up
Clinical success
Time frame: Up to 12 months of follow-up
Clinical success
Time frame: Up to 5 years of follow-up
Clinical success
Time frame: Up to 5 years of follow-up
Clinical success
Time frame: Up to 5 years of follow-up
Clinical success
Time frame: Up to 5 years of follow-up
Clinical success
Time frame: Up to 5 years of follow-up
Clinical success
Time frame: Up to 5 years of follow-up
Results and safety
The study was stopped early (reason given: Finance stop). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Reijnen, MD, PhD principal investigator
Principal Investigator
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorto-Iliac Atherosclerosis and Aortoiliac Obstruction, run by Rijnstate Hospital at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, New Zealand, Australia, Italy, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Finance stop). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.