Ischemic StrokeBRAVONCT05503212
Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral Artery Occlusions
An observational study of Ischemic Stroke and Vertebral Artery Ischemia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Isolated vertebral artery occlusions (VAO) account for approximately one third of posterior circulation occlusions, but have been given the least attention among posterior circulation strokes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Vertebral Artery Ischemia, Arterial Occlusive Diseases
- What is being tested?
- Conservative treatment (CT), Intravenous thrombolysis (IVT) and Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)
- Type of treatment
- Injection or infusion
- How many people
- 682 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2003to 9 Aug 2023
- 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: Patients with acute ischemic stroke and concomitant isolated vertebral artery occlusion accounting for stroke symptoms
Who may be able to join
- Acute ischemic stroke limited to the posterior circulation
- Presence of uni- or bilateral VAO (intracranial and/or extracranial) on at least one initial imaging study (CTA, MRA, DSA)
- IVT, EVT or bridging-treated stroke patients between 01.01.2003 and 31.12.2021
- ≥ 18 years old
Who cannot join
- Extension of the occlusion into the basilar artery
- Presence of a more distal occlusion in the pc (tandem occlusion/multilevel poster circulation occlusions)
- Previously known chronic occlusion of the any segment of the vertebral artery/arteries
- Local ethical/legal conditions in participating center not fulfilled
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral : the BRAVO Retrospective Analysis
Isolated vertebral artery occlusions (VAO) account for approximately one third of posterior circulation occlusions, but have been given the least attention among posterior circulation strokes. If the two recent ATTENTION and BAOCHE randomized clinical trials have proven the superiority of endovascular thrombectomy (EVT) in basilar artery occlusions, data on the effectiveness and harm of acute revascularization treatment on isolated VAO is scarce. We aim to investigate the impact of acute recanalisation treatments in acute ischemic stroke patients with isolated VAO.
In the absence of RCT, observational data with appropriate statistical methods may give indications on benefits and harms of treating neglected stroke situations like acute vertebral occlusion. Results may also lay the basis for prospective studies, such as randomized clinical trials.
- Conditions
- Ischemic Stroke, Vertebral Artery Ischemia, Arterial Occlusive Diseases, Vertebrobasilar Insufficiency
- Being tested
- Conservative treatment (CT), Intravenous thrombolysis (IVT), Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)
- Keywords
- Prognosis, Revascularization, Treatment
- Medical subject headings
- Ischemic Stroke, Vertebrobasilar Insufficiency, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment (CT)Other
Best medical treatment without intravenous thrombolysis nor endovascular thrombectomy
Intravenous thrombolysis (IVT)Other
Best medical treatment with intravenous thrombolysis but without endovascular thrombectomy
Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)Other
Best medical treatment with endovascular thrombectomy with or without intravenous thrombolysis
| Study group | Role | What they receive |
|---|---|---|
| AIS and isolated VAO | Patients with acute ischemic stroke (AIS) and concomitant isolated intracranial and/or extracranial vertebral artery occlusion (VAO) Receives: Other: Conservative treatment (CT); Other: Intravenous thrombolysis (IVT); Other: Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month modified Rankin scale
3-month functional outcome, [range: 0-6, 0= no symptoms, 6=death]
Measured: 90 days
Secondary outcomes (7)
Symptomatic intracerebral haemorrhage (sICH)
Any hemorrhagic transformation temporally related to any worsening in neurological condition. [yes/no]
Measured: 7 days
EVT procedural complications
Any complication attributed to the procedure (vessel perforation, vasospasm, dissection, Subarachnoid haemorrhage (SAH)/Intracerebral haemorrhage (ICH), device detachment/misplacement, embolization to new territory, access-site complications, early reocclusion, other)
Measured: During EVT procedure or peri-procedural
24-hour NIHSS
NIH Stroke Scale/Score (NIHSS). Quantifies stroke severity based on weighted clinical evaluation findings at 24h. [0-42, 0= no deficit, 42=maximum stroke severity]
Measured: 24 hours
Early neurological deterioration (ENDi)
Early neurological deterioration of ischemic origin (ENDi) is defined as an increase in National Institute of Health Stroke (NIHSS) score ≥ 4 points or death within 24 hours. [yes/no]
Measured: 24 hours
Cerebrovascular ischemic recurrences
Any ischemic stroke or transient ischemic attack recurrence [yes/no]
Measured: 90 days
24h and 3month mortality
Mortality at 24h and 3 months
Measured: 24h and 90 days
Vessel recanalisation on follow up-imaging
Vessel recanalisation at follow-up imaging (0= no recanalisation, 1= partial recanalisation 50-99%, 2=full recanalisation, 3= initially not occluded)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jan 2003
- Primary completion9 Aug 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Retrospective
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, St John of God Hospital, Vienna, Medical University Innsbruck, Hospital Vall d'Hebron, University Hospital, Basel, Switzerland, Clinical Centre of Serbia, Charite University, Berlin, Germany, Insel Gruppe AG, University Hospital Bern, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Boston Medical Center, Università degli Studi di Brescia, Cooper Norcross Health, University Hospital Carl Gustav Carus, Duke University, University Hospital, Geneva, Hadassah Medical Organization, Sahlgrenska University Hospital, Universitätsklinikum Hamburg-Eppendorf, Helsinki University Central Hospital, The University of Texas Health Science Center, Houston, University Hospital, Lille, Hospital de Egas Moniz, Neurocenter of Southern Switzerland, Corewell Health West, Azienda Ospedaliero-Universitaria di Modena, Ludwig-Maximilians - University of Munich, Azienda USL Reggio Emilia - IRCCS, University of Zurich
- Responsible party
- Principal investigator, Dr. med. Alexander Salerno, MD, Centre Hospitalier Universitaire Vaudois
- Investigators
- Dr. med. Alexander Salerno, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503212
- Sponsor's protocol ID
- Stroke-VAO
- Acronym
- BRAVO
- Status last verified
- Aug 2023
- First submitted
- 22 Mar 2022
- Last updated
- 14 Aug 2023
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral : the BRAVO Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05503212
- Acronym / sponsor ID
- BRAVO / Stroke-VAO
- Conditions
- Ischemic Stroke, Vertebral Artery Ischemia, Arterial Occlusive Diseases, Vertebrobasilar Insufficiency
- Keywords
- Prognosis, Revascularization, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Asan Medical Center, St John of God Hospital, Vienna, Medical University Innsbruck, Hospital Vall d'Hebron, University Hospital, Basel, Switzerland, Clinical Centre of Serbia, Charite University, Berlin, Germany, Insel Gruppe AG, University Hospital Bern, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Boston Medical Center, Università degli Studi di Brescia, Cooper Norcross Health, University Hospital Carl Gustav Carus, Duke University, University Hospital, Geneva, Hadassah Medical Organization, Sahlgrenska University Hospital, Universitätsklinikum Hamburg-Eppendorf, Helsinki University Central Hospital, The University of Texas Health Science Center, Houston, University Hospital, Lille, Hospital de Egas Moniz, Neurocenter of Southern Switzerland, Corewell Health West, Azienda Ospedaliero-Universitaria di Modena, Ludwig-Maximilians - University of Munich, Azienda USL Reggio Emilia - IRCCS, University of Zurich
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 16 Aug 2022 (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.
Isolated vertebral artery occlusions (VAO) account for approximately one third of posterior circulation occlusions, but have been given the least attention among posterior circulation strokes. If the two recent ATTENTION and BAOCHE randomized clinical trials have proven the superiority of endovascular thrombectomy (EVT) in basilar artery occlusions, data on the effectiveness and harm of acute revascularization treatment on isolated VAO is scarce. We aim to investigate the impact of acute recanalisation treatments in acute ischemic stroke patients with isolated VAO.
In the absence of RCT, observational data with appropriate statistical methods may give indications on benefits and harms of treating neglected stroke situations like acute vertebral occlusion. Results may also lay the basis for prospective studies, such as randomized clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIS and isolated VAO | – | Other: Conservative treatment (CT), Other: Intravenous thrombolysis (IVT), Other: Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)Patients with acute ischemic stroke (AIS) and concomitant isolated intracranial and/or extracranial vertebral artery occlusion (VAO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke and concomitant isolated vertebral artery occlusion accounting for stroke symptoms
Key inclusion criteria (4 listed)
- Acute ischemic stroke limited to the posterior circulation
- Presence of uni- or bilateral VAO (intracranial and/or extracranial) on at least one initial imaging study (CTA, MRA, DSA)
- IVT, EVT or bridging-treated stroke patients between 01.01.2003 and 31.12.2021
- ≥ 18 years old
Key exclusion criteria (4 listed)
- Extension of the occlusion into the basilar artery
- Presence of a more distal occlusion in the pc (tandem occlusion/multilevel poster circulation occlusions)
- Previously known chronic occlusion of the any segment of the vertebral artery/arteries
- Local ethical/legal conditions in participating center not fulfilled
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 |
|---|---|---|
| Conservative treatment (CT)Best medical treatment without intravenous thrombolysis nor endovascular thrombectomy | Other | AIS and isolated VAO |
| Intravenous thrombolysis (IVT)Best medical treatment with intravenous thrombolysis but without endovascular thrombectomy | Other | AIS and isolated VAO |
| Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)Best medical treatment with endovascular thrombectomy with or without intravenous thrombolysis | Other | AIS and isolated VAO |
Primary outcome
3-month modified Rankin scale
Time frame: 90 days
3-month functional outcome, [range: 0-6, 0= no symptoms, 6=death]
7 secondary outcomes
Symptomatic intracerebral haemorrhage (sICH)
Time frame: 7 days
EVT procedural complications
Time frame: During EVT procedure or peri-procedural
24-hour NIHSS
Time frame: 24 hours
Early neurological deterioration (ENDi)
Time frame: 24 hours
Cerebrovascular ischemic recurrences
Time frame: 90 days
24h and 3month mortality
Time frame: 24h and 90 days
Vessel recanalisation on follow up-imaging
Time frame: 48 hours
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 14 Aug 2023.
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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.
Dr. med. Alexander Salerno, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Vertebral Artery Ischemia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 4 inclusion and 4 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
3-month modified Rankin scale (time frame: 90 days). 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 14 Aug 2023.