Aortic Arch AneurysmNCT04489277
Silent Brain Infarction After Endovascular Arch Procedures
An observational study of Aortic Arch Aneurysm, run by Medical University of Vienna at 2 sites in 2 countries.
Trial summary
This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Arch Aneurysm
- What is being tested?
- Endovascular Arch Procedures
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2018to 31 Jan 2020
- How long will I take part?
- 17 Months
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients, who received routine postoperative DW-MRI within 7 days after endovascular aortic arch repair between September 2018 and January 2020 at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) and Marie Lannelongue Hospital (Paris, France) were identified.
Who may be able to join
- Included patients underwent a proximal endograft deployment in Ishimaru zone 0 to 3
Who cannot join
- Missing preoperative computed tomography angiography (CTA) scan of the chest and any circumstances that precluded the DW-MRI to be performed in the appropriate time window, such as a medical condition or an MRI contraindication
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
University Hospital Hamburg-Eppendorf (Hamburg, Germany)
Hamburg
About this study
Official title: Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results From the STEP Registry
This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization.
Read the detailed description
Introduction. Poor data exist concerning the rate of silent cerebral ischemic events following endovascular treatment of the aortic arch. The objective of this work was to quantify these lesions using the STEP registry.
Methods. This multicentre retrospective cohort study included consecutive patients treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed to identify the location and number of new silent brain infarctions (SBI), microbleeds ans general outcome of the patients.
- Conditions
- Aortic Arch Aneurysm
- Being tested
- Endovascular Arch Procedures
- Keywords
- Thoracic endovascular aortic repair, Silent cerebral infarction, Stroke, Magnetic resonance imaging, DW-MRI, Aortic arch disease
- Medical subject headings
- Aneurysm, Aortic Arch, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Arch ProceduresDevice
Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)
| Study group | Role | What they receive |
|---|---|---|
| Patients with Silent Brain Infarction | treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure with silent brain infarction Receives: Device: Endovascular Arch Procedures | |
| Patients without Silent Brain Infarction | treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure without silent brain infarction Receives: Device: Endovascular Arch Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of silent cerebral infarcts on DW-MRI
Primary outcomes were the frequency of silent cerebral infarcts on DW-MRI after endovascular arch procedures, and to identify the number, the distribution, and predictors of these lesions.
Measured: 7 days
Secondary outcomes (1)
perioperative ischemic stroke
Secondary outcomes were perioperative ischemic stroke defined as a brain infarction of ischemic etiology which occurs during surgery or within 30 days after surgery, TIA, hemorrhagic stroke, 30-day mortality, spinal cord ischemia, length of stay and discharge disposition.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Sep 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Arch AneurysmStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 91 participants (actual)
- Target duration
- 17 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Hôpital Saint-Joseph, Universitätsklinikum Hamburg-Eppendorf, Vascular Surgical Research Group, Imperial College, London, UK, Sanger Heart and Vascular Institute, Charlotte, NC, Loyola University Medical Center, Maywood, IL, UAB School of Medicine, Birmingham, AL, University Hospital Heidelberg, University Hospital Freiburg, Stanford University, Massachusetts General Hospital, Baylor College of Medicine, Emory University Hospital, Atlanta, GA, University Hospital of Mainz, Mainz, Germany, Jung Stilling Hospital, Mayo Clinic, Rochester, MN, Sentara Vascular/Eastern Virginia Medical School, Norfolk, VA, Maastricht University Medical Centre, Maastricht, Netherlands, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy, Memorial Care Long Beach Heart & Vascular Institute, Long Beach, CA
- Responsible party
- Principal investigator, Wolf Eilenberg, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489277
- Sponsor's protocol ID
- INSERM UMR_S 999
- Status last verified
- Aug 2020
- First submitted
- 23 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charbonneau P, Kolbel T, Rohlffs F, Eilenberg W, Planche O, Bechstein M, Ristl R, Greenhalgh R, Haulon S; STEP collaborators. Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results from the STEP Registry. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):239-245. doi: 10.1016/j.ejvs.2020.11.021. Epub 2020 Dec 22.
PubMed 33358103
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results From the STEP Registry
- ClinicalTrials.gov ID
- NCT04489277
- Acronym / sponsor ID
- INSERM UMR_S 999
- Conditions
- Aortic Arch Aneurysm
- Keywords
- Thoracic endovascular aortic repair, Silent cerebral infarction, Stroke, Magnetic resonance imaging, DW-MRI, Aortic arch disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Fondation Hôpital Saint-Joseph, Universitätsklinikum Hamburg-Eppendorf, Vascular Surgical Research Group, Imperial College, London, UK, Sanger Heart and Vascular Institute, Charlotte, NC, Loyola University Medical Center, Maywood, IL, UAB School of Medicine, Birmingham, AL, University Hospital Heidelberg, University Hospital Freiburg, Stanford University, Massachusetts General Hospital, Baylor College of Medicine, Emory University Hospital, Atlanta, GA, University Hospital of Mainz, Mainz, Germany, Jung Stilling Hospital, Mayo Clinic, Rochester, MN, Sentara Vascular/Eastern Virginia Medical School, Norfolk, VA, Maastricht University Medical Centre, Maastricht, Netherlands, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy, Memorial Care Long Beach Heart & Vascular Institute, Long Beach, CA
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 28 Jul 2020 (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.
This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization.
Detailed description
Introduction. Poor data exist concerning the rate of silent cerebral ischemic events following endovascular treatment of the aortic arch. The objective of this work was to quantify these lesions using the STEP registry.
Methods. This multicentre retrospective cohort study included consecutive patients treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed to identify the location and number of new silent brain infarctions (SBI), microbleeds ans general outcome of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 17 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Silent Brain Infarction | – | Device: Endovascular Arch Procedurestreated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure with silent brain infarction |
| Patients without Silent Brain Infarction | – | Device: Endovascular Arch Procedurestreated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure without silent brain infarction |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients, who received routine postoperative DW-MRI within 7 days after endovascular aortic arch repair between September 2018 and January 2020 at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) and Marie Lannelongue Hospital (Paris, France) were identified.
Key inclusion criteria (1 listed)
- Included patients underwent a proximal endograft deployment in Ishimaru zone 0 to 3
Key exclusion criteria (1 listed)
- Missing preoperative computed tomography angiography (CTA) scan of the chest and any circumstances that precluded the DW-MRI to be performed in the appropriate time window, such as a medical condition or an MRI contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Arch ProceduresEndovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts) | Device | Patients with Silent Brain Infarction, Patients without Silent Brain Infarction |
Primary outcome
frequency of silent cerebral infarcts on DW-MRI
Time frame: 7 days
Primary outcomes were the frequency of silent cerebral infarcts on DW-MRI after endovascular arch procedures, and to identify the number, the distribution, and predictors of these lesions.
1 secondary outcome
perioperative ischemic stroke
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Derived from this study: PubMed 33358103Charbonneau P, Kolbel T, Rohlffs F, Eilenberg W, Planche O, Bechstein M, Ristl R, Greenhalgh R, Haulon S; STEP collaborators. Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results from the STEP Registry. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):239-245. doi: 10.1016/j.ejvs.2020.11.021. Epub 2020 Dec 22.
- Individual participant dataSharing planned: No
Related trials for Aortic Arch Aneurysm
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm
Not yet recruiting
A Novel Wire-Reinforced Fenestration of a Hybrid Frozen Elephant Trunk Device for Supra-Aortic Branch Vessel Stenting During Aortic Arch Replacement
Aortic Aneurysm, Aortic Dissection
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Arch Aneurysm, run by Medical University of Vienna at 2 sites in 2 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
frequency of silent cerebral infarcts on DW-MRI (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489277, which also lists 1 linked publication.
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 6 Aug 2020.