Cerebrovascular StrokeSTRAITNCT05361187
BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
An observational study of Cerebrovascular Stroke, run by Microvention-Terumo, Inc. at 9 sites in 2 countries.
Trial summary
Evaluation of the safety and performance of the BOBBY™ Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebrovascular Stroke
- What is being tested?
- BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device
- Type of treatment
- Medical device
- How many people
- 171 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 8 Apr 2022to 30 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from an anterior circulation acute ischemic stroke eligible to mechanical thrombectomy using a BOBBY™ Balloon Guide Catheter will be screened consecutively by the enrolling center. The patients will be selected in accordance with inclusion and exclusion criteria.
Who may be able to join
- Patient is ≥ 18 and ≤ 85 years of age
- Informed consent by the patient or legal authorized representative for data collection is obtained
- Patient eligible for the mechanical thrombectomy treatment with adjunctive use of the BOBBY™ BGC
- Patient presenting with an anterior circulation large-vessel occlusion of distal internal carotic artery (ICA ) through proximal M2 confirmed by computed tomograph angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
- Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based on baseline CT or MR imaging
- Treatment initiated (groin puncture) within 8 hours of symptom onset.
- Patient with a pre-treatment National Institutes of Health Stroke Scale (NIHSS) score ≥5
- Patient with no personal condition disabling the site to contact him/her at 90 days after procedure
Who cannot join
- Patient has evidence of cerebral ischemia in the posterior circulation
- Patient presents severe unilateral or bilateral carotid artery stenosis requiring stent treatment during the procedure
- Pregnancy or breastfeeding
- Patient presents other serious medical illness (e.g., cancer) with estimated life expectancy of less than 3 months
- Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation
- Patient is already participating in an investigational drug or device trial (change routine care of the patient)
- Patient has evidence of intracerebral hemorrhage on initial imaging
- Patient has a significant mass effect with midline shift
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany6 sites
Martin Luther Universität Halle
Halle, Halle, 06120
Neurologische Klinik Abteilung für Neuroradiologie
Heidelberg
Klinikum Ingolstadt, Zentrum für Radiologie und Neuroradiologie
Ingolstadt
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel
Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria
Department of Neuroradiology, University Hospital of Paracelsus Medical Private University
Nuremberg
Switzerland3 sites
Devision Neuroradiology, Kantonsspital Aarau
Aarau
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne
Department of Neuroradiology, University hospital Zürich
Zurich
About this study
Official title: STRAIT: Evaluation of Safety and Performance of the BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
Evaluation of the safety and performance of the BOBBY™ Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). To prevent clot particles migrating in other parts of the brain circulation during the thrombectomy, balloon guiding catheters are inserted. The aim of the study is to evaluate the safety and performance of the balloon guide catheter BOBBY™ by collecting information from patients, treated with a mechanical thrombectomy and the balloon guide catheter (BOBBY™) after acute ischemic stroke
Read the detailed description
The main objective of the STRAIT study is to assess the performance of the mechanical thrombectomy using a BOBBY™ Balloon Guide Catheter (BGC) as adjunctive device for endovascular treatment of patients suffering from an anterior circulation acute ischemic stroke. Interventional procedures and clinical follow-up will be performed per standard of care. Patient health-related and imaging data will be collected as of stroke onset time up to 90 days follow up.
- Conditions
- Cerebrovascular Stroke
- Being tested
- BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device
- Keywords
- Cerebrovascular Stroke, Thrombectomy, Balloon Guide Catheter
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive deviceDevice
The BOBBY™ BGC used during a mechanical thrombectomy procedure (stent retriever alone, contact aspiration alone or stent retriever and contact aspiration) and according to the instruction for use (IFU).
| Study group | Role | What they receive |
|---|---|---|
| single arm, observational post market study | Patients with an acute ischemic stroke with treatment including the BOBBY™ BGC Receives: Device: BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the proportion of patients with successful reperfusion defined as mTICI≥2b per Core Laboratory evaluation.
Successful reperfusion defined as mTICI≥2b by independent Core Laboratory evaluation.
Measured: 90 days
Secondary outcomes (10)
Technical success: successful placement of the BOBBY™ BGC at the skull base
Bobby catheter placement evaluated at predefined segments (cervical, petrous, cavernous, paraclinoid) of the internal carotic artery (ICA) per independent Core Laboratory evaluation
Measured: 90 days
Near complete reperfusion defined as mTICI≥2c
mTICI evaluation per independent Core Lab members
Measured: 90 days
Patients with modified First Pass Effect observed (mFPE: mTICI≥2b after one pass)
mTICI result after first pass evaluated by independent Core Lab members
Measured: 90 days
90 days post-procedure modified Ranking Scale (mRS)
modified Ranking Scale (mRS) assessment and questionnaire at 90 days follow up visit.
The mRS has a scale from 0 till 6. 0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead
Measured: 90 days
Mortality at 24 hours and 90 days
Serious adverse event evaluation validated by clinical event committee
Measured: 24 hours and 90 days
Safety evaluation device malfunction
Device related adverse event evaluation and follow up, validated by clinical event committee
Measured: 90 days
NIHSS at 24h post-procedure
NIHSS (National Institut Health Stroke Scale) evaluation by questionnaire to assess worsening of condition compared to baseline.
The NIHSS score covers 11 specific ability items. Each item can been scored between 0 and 4, with 0 indicating a normal function and higher scores indicating the lever of impairment. The total summ of all the ablity items is the total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
0 No stroke symptoms, 1-4, Minor stroke, 5-15 Moderate stroke,16-20 Moderate to severe stroke, 21-42 Severe stroke
Measured: 24 hours
Procedure related events
Procedure related events and outcome evaluation validated
Measured: 24 hours
Occurence of new territory embolization
Assessment by independent Core Lab members of DSA or MRA at the end of the procedure and at 24 hours
Measured: 24 hours
Occurrence of symptomatic intracranial hemorrhage (sICH) within 24 hours
procedure imaging assessment of imaging
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start8 Apr 2022
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Why it stopped: endpoint reached
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 Cerebrovascular StrokeStudies of the same condition, open and under way.
- More trials run by Microvention-Terumo, Inc.The 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Boeckh-Behrens, MD, Principal investigator, Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen UniversitätPatricia Boyer, Study director, Microvention-Terumo, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361187
- Sponsor's protocol ID
- STRAIT
- Acronym
- STRAIT
- Status last verified
- Jan 2025
- First submitted
- 13 Apr 2022
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boeckh-Behrens T, Maegerlein C, Kirschke JS, Wunderlich S, Mohlenbruch MA, Holtmannspoetter M, Janssen H, Wodarg F, Schob S, Gruber P, Remonda L, Kulcsar Z, Saliou G, Berndt MT. Performance of the new generation BOBBY balloon guide catheter for endovascular treatment of acute ischemic stroke: results of the prospective, multicentric STRAIT study. J Neurointerv Surg. 2026 Jun 23:jnis-2026-025301. doi: 10.1136/jnis-2026-025301. Online ahead of print.
PubMed 42336640
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRAIT: Evaluation of Safety and Performance of the BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05361187
- Acronym / sponsor ID
- STRAIT / STRAIT
- Conditions
- Cerebrovascular Stroke
- Keywords
- Cerebrovascular Stroke, Thrombectomy, Balloon Guide Catheter
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: endpoint reached
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 4 May 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.
Evaluation of the safety and performance of the BOBBY™ Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). To prevent clot particles migrating in other parts of the brain circulation during the thrombectomy, balloon guiding catheters are inserted. The aim of the study is to evaluate the safety and performance of the balloon guide catheter BOBBY™ by collecting information from patients, treated with a mechanical thrombectomy and the balloon guide catheter (BOBBY™) after acute ischemic stroke
Detailed description
The main objective of the STRAIT study is to assess the performance of the mechanical thrombectomy using a BOBBY™ Balloon Guide Catheter (BGC) as adjunctive device for endovascular treatment of patients suffering from an anterior circulation acute ischemic stroke. Interventional procedures and clinical follow-up will be performed per standard of care. Patient health-related and imaging data will be collected as of stroke onset time up to 90 days follow up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm, observational post market study | – | Device: BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive devicePatients with an acute ischemic stroke with treatment including the BOBBY™ BGC |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from an anterior circulation acute ischemic stroke eligible to mechanical thrombectomy using a BOBBY™ Balloon Guide Catheter will be screened consecutively by the enrolling center. The patients will be selected in accordance with inclusion and exclusion criteria.
Key inclusion criteria (8 listed)
- Patient is ≥ 18 and ≤ 85 years of age
- Informed consent by the patient or legal authorized representative for data collection is obtained
- Patient eligible for the mechanical thrombectomy treatment with adjunctive use of the BOBBY™ BGC
- Patient presenting with an anterior circulation large-vessel occlusion of distal internal carotic artery (ICA ) through proximal M2 confirmed by computed tomograph angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
- Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based on baseline CT or MR imaging
Key exclusion criteria (8 listed)
- Patient has evidence of cerebral ischemia in the posterior circulation
- Patient presents severe unilateral or bilateral carotid artery stenosis requiring stent treatment during the procedure
- Pregnancy or breastfeeding
- Patient presents other serious medical illness (e.g., cancer) with estimated life expectancy of less than 3 months
- Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation
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 |
|---|---|---|
| BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive deviceThe BOBBY™ BGC used during a mechanical thrombectomy procedure (stent retriever alone, contact aspiration alone or stent retriever and contact aspiration) and according to the instruction for use (IFU). | Device | single arm, observational post market study |
Primary outcome
The primary endpoint is the proportion of patients with successful reperfusion defined as mTICI≥2b per Core Laboratory evaluation.
Time frame: 90 days
Successful reperfusion defined as mTICI≥2b by independent Core Laboratory evaluation.
10 secondary outcomes
Technical success: successful placement of the BOBBY™ BGC at the skull base
Time frame: 90 days
Near complete reperfusion defined as mTICI≥2c
Time frame: 90 days
Patients with modified First Pass Effect observed (mFPE: mTICI≥2b after one pass)
Time frame: 90 days
90 days post-procedure modified Ranking Scale (mRS)
Time frame: 90 days
Mortality at 24 hours and 90 days
Time frame: 24 hours and 90 days
Safety evaluation device malfunction
Time frame: 90 days
NIHSS at 24h post-procedure
Time frame: 24 hours
Procedure related events
Time frame: 24 hours
Occurence of new territory embolization
Time frame: 24 hours
Occurrence of symptomatic intracranial hemorrhage (sICH) within 24 hours
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: endpoint reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Derived from this study: PubMed 42336640Boeckh-Behrens T, Maegerlein C, Kirschke JS, Wunderlich S, Mohlenbruch MA, Holtmannspoetter M, Janssen H, Wodarg F, Schob S, Gruber P, Remonda L, Kulcsar Z, Saliou G, Berndt MT. Performance of the new generation BOBBY balloon guide catheter for endovascular treatment of acute ischemic stroke: results of the prospective, multicentric STRAIT study. J Neurointerv Surg. 2026 Jun 23:jnis-2026-025301. doi: 10.1136/jnis-2026-025301. Online ahead of print.
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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.
Tobias Boeckh-Behrens, MD principal investigator
Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität
Patricia Boyer study director
Microvention-Terumo, Inc.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Stroke, run by Microvention-Terumo, Inc. at 9 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 8 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 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, 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 was stopped early (reason given: endpoint reached). 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?
The primary endpoint is the proportion of patients with successful reperfusion defined as mTICI≥2b per Core Laboratory evaluation. (time frame: 90 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 NCT05361187, 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 7 Jan 2025.