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Acute Ischemic Stroke PatientsBESTNCT07478042

Guiding Catheters in Endovascular Stroke Therapy - Are Balloon Guided Catheters Superior?

A study testing Ballon guide catheter and Guide catheter without balloon in people with Acute Ischemic Stroke Patients and Acute Ischemic Stroke, run by University Hospital Heidelberg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The BEST study is an academically initiated, single-center, prospective, randomized controlled clinical trial investigating the potential advantages and disadvantages of using a guide catheter with or without a balloon in the interventional treatment of acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ballon guide catheter and Guide catheter without balloon
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteGermany
Study dates
15 Mar 2023to 30 Sep 2025
Phase
Interventional
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

Who may be able to join

  • Patients with an acute ischemic stroke
  • Location of the primary occlusion in the anterior cerebral circulation
  • Pre-therapeutic modified Rankin Scale (mRS) score of ≤ 3.
  • Written informed consent from
  • the patient or
  • their legal representative/guardian or
  • patient enrollment by an independent physician and the principal investigator

Who cannot join

  • Patients with contraindications to interventional therapy
  • Patients with acute intracranial hemorrhage
  • Pregnancy/Breastfeeding
  • Pre-therapeutic mRS > 3
  • National Institute of Health Stroke Scale (NIHSS) ≤ 4
  • Patients detained in an institution by court or government order
  • Patients who require intubation for treatment

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

Official title: Sind Ballonassistierte Führungskatheter in Der Endovaskulären Schlaganfalltherapie Der Vorderen Zirkulation überlegen? (BEST-Studie) Guiding Catheters in Endovascular Stroke Therapy - Are Balloon Guided Catheters Superior?

The BEST study is an academically initiated, single-center, prospective, randomized controlled clinical trial investigating the potential advantages and disadvantages of using a guide catheter with or without a balloon in the interventional treatment of acute ischemic stroke.

The study population consists of adult patients with acute ischemic stroke of the anterior circulation for whom interventional recanalization therapy via catheter is indicated following interdisciplinary consultation between the Department of Neurology and Neuroradiology at Heidelberg University Hospital.

Read more

In addition to routine clinical treatment measures and data collection, patients will be interviewed by telephone after 90 days to assess their quality of life and level of independence using standardized scoring systems.

All medical devices used or investigated in this study bear the CE mark (Conformité Européenne ) and will be used within their intended purpose. Study participants will not be subjected to any additional invasive or burdensome procedures beyond normal usage.

Read the detailed description

Are balloon guide catheters in endovascular stroke therapy of the anterior circulation superior? (BEST) Background Meta-analyses on the use of balloon-guided catheters (BGK) suggest a better technical and clinical outcome after endovascular stroke therapy (EST). However, no randomised controlled trials exist to support these results, yet.

Study objective To investigate whether usage of BGK for EST of anterior circulation ischemic stroke due to large vessel occlusion results in improved degree of recanalization of the target vessel and the associated vascular territory.

Study population N = 110 patients (55 per group, 1:1 randomisation) with acute ischemic stroke due to large vessel occlusion of the anterior circulation and intention to treatment with EST.

Inclusion criteria

  1. Patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation (internal carotid artery-T, M1 (segment of the middle cerebral artery) or proximal M2 (M2 segment of the middle cerebral artery) occlusion) proven by either computed tomography (CT) or magentic resonance imaging (MRI)
  2. Estimated time between stroke onset / last seen well and study procedure of < 24 hours
  3. No relevant pre-stroke functional disability (pre-morbid modified Rankin Sacle (mRS) of 0 - 3)
  4. Neurological deficit with a National Instutute of Health Stroke Scale (NIHSS) of ≥ 4 and ≤ 25
  5. Age ≥ 18
  6. Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 on baseline non-contrast CT < 4,5h after onset or CT perfusion / MRI > 4,5h after onset

Exclusion criteria

  1. Pre-existing stenosis in the target vessel requiring stent therapy
  2. Tandem occlusions of both cervical and intracranial vessels
  3. Prior intracranial hemorrhage or signs of intracranial hemorrhage during procedure
  4. Notably increased risk of intracranial hemorrhage
  5. Excessive vascular tortuosity that will likely result in unstable access or inability to access the target vessel
  6. Dissection of the extra- or intracranial cerebral arteries
  7. Pregnant or breast-feeding women
  8. Known severe illness with life expectancy less than 6 months
  9. Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation

Intervention EST is performed with usage of either i) a BGK (Stryker MERCI 9F, Stryker Flowgate2 8F) or ii) a standard guide catheter without balloon (Cordis Vista Brite Tip 8F) Study design Mono-centric, prospective, parallel-group, randomized controlled trial with blinded endpoint evaluation (PROBE design) Clinical Site Location Heidelberg University Hospital, Germany Endpoints Primary endpoint: Proportion of patients with successful technical recanalisation (expanded treatment in cerebral infarction (eTICI) score 2c/3) Secondary endpoint (selected): Clinical outcome after 90 days using the modified Rankin Scale (mRS); severity of stroke symptoms after 24h measured by National Institute of Health Stroke Scale (NIHSS); Infarct Growth between baseline and first follow-up MRI measured by volume of lesion on diffusion-weighted imaging; volume and number of peripheral emboli on follow-up MRI measured on diffusion-weighted imaging; safety endpoints.

Participant duration 3 months Estimated Study duration 2-3 years

Being tested
Ballon guide catheter, Guide catheter without balloon
Keywords
mechanical thrombectomy, endovascular treatment, endovascular stroke therapy, balloon guide catheters
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ballon guide catheterDevice

    Mechanical thrombectomy is an endovascular treatment for acute ischemic stroke caused by a large-vessel occlusion. It involves advancing a catheter, with or without a balloon usually via the femoral or radial artery, to the occluded intracranial artery and mechanically removing the thrombus using a stent retriever, aspiration device, or a combination of both.

  • Guide catheter without balloonDevice

    Thrombectomy of acute ischemic stroke using a guide catheter without balloon

Study groups in NCT07478042
Study groupRoleWhat they receive
Ballon guide catheterActive comparatorThrombectomy of an acute ischemic stroke using a balloon-guided catheter
Receives: Device: Ballon guide catheter
Guide catheter without balloonPlacebo comparatorThrombectomy of an acute ischemic stroke using a guide catheter without balloon
Receives: Device: Guide catheter without balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful recanalisation

    expanded treatment in cerebral ischemia (eTICI) Score ≥2c eTICI Grades: grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2A: reperfusion of 1-49% of the territory grade 2B50: reperfusion of 50-66% of the territory grade 2B67: reperfusion of 67-89% of the territory grade 2C: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion)

    Measured: up to day 1

Secondary outcomes (12)

  1. Modified Rankin Scale

    The Modified Rankin Scale (mRS) is a 7-point ordinal scale used to measure the degree of disability or dependence in daily activities, most commonly after stroke.

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

    Measured: Up to 90 days after treatment

  2. 24hr NIHSS

    The NIH Stroke Scale (NIHSS) is a standardized clinical scoring system used to quantify neurological deficit in patients with acute stroke. It assesses level of consciousness, language, motor strength, sensory function, visual fields, coordination, and neglect.

    Scores range from 0 (no deficit) to 42 (severe stroke), with higher scores indicating greater neurological impairment. NIHSS is widely used to guide acute treatment decisions, assess stroke severity, and predict clinical outcomes.

    Measured: 24 Hours after treatment

  3. 7d NIHSS

    The NIH Stroke Scale (NIHSS) is a standardized clinical scoring system used to quantify neurological deficit in patients with acute stroke. It assesses level of consciousness, language, motor strength, sensory function, visual fields, coordination, and neglect.

    Scores range from 0 (no deficit) to 42 (severe stroke), with higher scores indicating greater neurological impairment. NIHSS is widely used to guide acute treatment decisions, assess stroke severity, and predict clinical outcomes.

    Measured: Up tp Day 7 after treatment

  4. Technical success

    The expanded Thrombolysis in Cerebral Infarction (eTICI) score is an angiographic grading scale used to assess the degree of cerebral reperfusion after endovascular treatment in acute ischemic stroke.

    It ranges from 0 (no reperfusion) to 3 (complete reperfusion), with intermediate grades reflecting increasing levels of partial reperfusion. The eTICI score is commonly used to evaluate the technical success of mechanical thrombectomy, with eTICI 2b-3 generally considered successful reperfusion.

    eTICI Grades: grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2A: reperfusion of 1-49% of the territory grade 2B50: reperfusion of 50-66% of the territory grade 2B67: reperfusion of 67-89% of the territory grade 2C: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion)

    Measured: Periprocedural

  5. First-Pass-Effekt, Number of Participants with reperfusion on first pass

    The First-Pass Effect (FPE) in mechanical thrombectomy describes the achievement of successful reperfusion after a single thrombectomy device pass, without the need for additional attempts.

    It is typically defined as eTICI 2c or 3 reperfusion on the first pass. The First-Pass Effect is clinically relevant because it is associated with shorter procedure times, less endothelial injury, fewer complications, and better functional outcomes compared with reperfusion requiring multiple passes.

    Measured: Periprocedural

  6. Time to visualization

    Time interval between the start of thrombectomy and visualization of the occlusion, in minutes

    Measured: Periprocedural

  7. Time to first pass

    Time interval between the start of thrombectomy and the first recanalization maneuver, in minutes

    Measured: Periprocedural

  8. Time to success

    Time interval between the start of thrombectomy and successful recanalization defined as eTICI 2c or 3 reperfusion, in minutes

    Measured: Periprocedural

  9. Number of Passes

    Number of passes / manouvers done required to achieve recanalization or unsuccessful termination of treatment determined by treating physician

    Measured: Periprocedural

  10. Number of Participants with Distal emboli

    Embolization in previously unaffected territories during thrombectomy

    Measured: Periprocedural

  11. Infarct growth

    Infarct growth between imaging before therapy and 24-48 hours after treatment

    Measured: up to 48 hours after treatment

  12. Number of emboli

    Number and volume of peripheral emboli (measured in diffusion-weighted imaging of the follow-up MRI examination)

    Measured: Day 1 - 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start15 Mar 2023
  3. Primary completion30 Jul 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Mono-centric, prospective, parallel-group, randomized controlled trial with blinded endpoint evaluation (PROBE design)
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07478042
Sponsor's protocol ID
BEST S-044/2023
Acronym
BEST
Status last verified
Jan 2026
First submitted
10 Feb 2026
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD may not be shared since participants have not consented to secondary use or data sharing.

Publications

  • Golubkina NA, Kosheleva OV, Ermakova RA, Filonova GL. [The stability of vitamin C in powdered mixes for beverages]. Vopr Pitan. 1991 Jul-Aug;(4):60-2. Russian.

    PubMed 1792753

  • Liebeskind DS, Bracard S, Guillemin F, Jahan R, Jovin TG, Majoie CB, Mitchell PJ, van der Lugt A, Menon BK, San Roman L, Campbell BC, Muir KW, Hill MD, Dippel DW, Saver JL, Demchuk AM, Davalos A, White P, Brown S, Goyal M; HERMES Collaborators. eTICI reperfusion: defining success in endovascular stroke therapy. J Neurointerv Surg. 2019 May;11(5):433-438. doi: 10.1136/neurintsurg-2018-014127. Epub 2018 Sep 7.

    PubMed 30194109

  • Bourcier R, Marnat G, Labreuche J, Desal H, Maria FD, Consoli A, Eugene F, Gory B, Dargazanli C, Blanc R, Lapergue B. Balloon Guide Catheter is Not Superior to Conventional Guide Catheter when Stent Retriever and Contact Aspiration are Combined for Stroke Treatment. Neurosurgery. 2020 Dec 15;88(1):E83-E90. doi: 10.1093/neuros/nyaa315.

    PubMed 32717034

  • Pederson JM, Reierson NL, Hardy N, Touchette JC, Medam S, Barrett A, Schmidt M, Brinjikji W, Kallmes DF, Kallmes KM. Comparison of Balloon Guide Catheters and Standard Guide Catheters for Acute Ischemic Stroke: A Systematic Review and Meta-Analysis. World Neurosurg. 2021 Oct;154:144-153.e21. doi: 10.1016/j.wneu.2021.07.034. Epub 2021 Jul 16.

    PubMed 34280538

  • Campbell BCV, Donnan GA, Lees KR, Hacke W, Khatri P, Hill MD, Goyal M, Mitchell PJ, Saver JL, Diener HC, Davis SM. Endovascular stent thrombectomy: the new standard of care for large vessel ischaemic stroke. Lancet Neurol. 2015 Aug;14(8):846-854. doi: 10.1016/S1474-4422(15)00140-4. Epub 2015 Jun 25.

    PubMed 26119323

  • Roman LS, Menon BK, Blasco J, Hernandez-Perez M, Davalos A, Majoie CBLM, Campbell BCV, Guillemin F, Lingsma H, Anxionnat R, Epstein J, Saver JL, Marquering H, Wong JH, Lopes D, Reimann G, Desal H, Dippel DWJ, Coutts S, du Mesnil de Rochemont R, Yavagal D, Ferre JC, Roos YBWEM, Liebeskind DS, Lenthall R, Molina C, Al Ajlan FS, Reddy V, Dowlatshahi D, Sourour NA, Oppenheim C, Mitha AP, Davis SM, Weimar C, van Oostenbrugge RJ, Cobo E, Kleinig TJ, Donnan GA, van der Lugt A, Demchuk AM, Berkhemer OA, Boers AMM, Ford GA, Muir KW, Brown BS, Jovin T, van Zwam WH, Mitchell PJ, Hill MD, White P, Bracard S, Goyal M; HERMES collaborators. Imaging features and safety and efficacy of endovascular stroke treatment: a meta-analysis of individual patient-level data. Lancet Neurol. 2018 Oct;17(10):895-904. doi: 10.1016/S1474-4422(18)30242-4. Epub 2018 Sep 18.

    PubMed 30264728

  • Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

    PubMed 26898852

Questions about this trial

What is this clinical trial studying?

A study testing Ballon guide catheter and Guide catheter without balloon in people with Acute Ischemic Stroke Patients and Acute Ischemic Stroke, run by University Hospital Heidelberg at 1 site in Germany.

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 7 inclusion and 7 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 17 Mar 2026. 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 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. Some participants in this study may receive a placebo. 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?

Successful recanalisation (time frame: up to day 1). 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 NCT07478042, which also lists 7 linked publications.

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 17 Mar 2026.

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