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

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.

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke; Acute Ischemic Stroke AIS; Acute Ischemic Stroke Patients
• Intervention / Treatment: Device: Ballon guide catheter; Device: Guide catheter without balloon

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

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • University Hospital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

  1. the patient or
  2. their legal representative/guardian or
  3. patient enrollment by an independent physician and the principal investigator

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ballon guide catheter; Thrombectomy of an acute ischemic stroke using a balloon-guided catheter	Device: Ballon guide catheter; 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.
Placebo Comparator: Guide catheter without balloon; Thrombectomy of an acute ischemic stroke using a guide catheter without balloon	Device: Guide catheter without balloon; Thrombectomy of acute ischemic stroke using a guide catheter without balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	up to day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.; - 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.	Up to 90 days after treatment
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.	24 Hours after treatment
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.	Up tp Day 7 after treatment
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)	Periprocedural
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.	Periprocedural
Time to visualization	Time interval between the start of thrombectomy and visualization of the occlusion, in minutes	Periprocedural
Time to first pass	Time interval between the start of thrombectomy and the first recanalization maneuver, in minutes	Periprocedural
Time to success	Time interval between the start of thrombectomy and successful recanalization defined as eTICI 2c or 3 reperfusion, in minutes	Periprocedural
Number of Passes	Number of passes / manouvers done required to achieve recanalization or unsuccessful termination of treatment determined by treating physician	Periprocedural
Number of Participants with Distal emboli	Embolization in previously unaffected territories during thrombectomy	Periprocedural
Infarct growth	Infarct growth between imaging before therapy and 24-48 hours after treatment	up to 48 hours after treatment
Number of emboli	Number and volume of peripheral emboli (measured in diffusion-weighted imaging of the follow-up MRI examination)	Day 1 - 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Proportion of patients who died after 90 days	up to 90 days after treatment
ICH	Number of patients with intracranial hemorrhage	Up to 90 days after treatment
Procedural complications	Number of procedural complications	Periprocedural

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Michael O Breckwoldt, MD, PhD, University Hospital Heidelberg; Study Director: Markus Möhlenbruch, MD, PhD, University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Lancet Neurol. 2018 Dec;17(12):e2-e3. doi: 10.1016/S1474-4422(18)30364-8.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: endovascular treatment; mechanical thrombectomy; endovascular stroke therapy; balloon guide catheters
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: BEST S-044/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD may not be shared since participants have not consented to secondary use or data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No