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

NCT07478042 | Completed

• 1 other identifier: BEST S-044/2023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Ischemic Stroke Patients; Acute Ischemic Stroke; Acute Ischemic Stroke AIS

Keywords

mechanical thrombectomy; endovascular treatment; endovascular stroke therapy; balloon guide catheters

Outcome Measures

Primary Outcomes (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)

  up to day 1

Secondary Outcomes (12)

• Modified Rankin Scale

  Up to 90 days after treatment

• 24hr NIHSS

  24 Hours after treatment

• 7d NIHSS

  Up tp Day 7 after treatment

• Technical success

  Periprocedural

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

  Periprocedural

Other Outcomes (3)

• Mortality

  up to 90 days after treatment

• ICH

  Up to 90 days after treatment

• Procedural complications

  Periprocedural

Study Arms (2)

Ballon guide catheter

ACTIVE COMPARATOR

Thrombectomy of an acute ischemic stroke using a balloon-guided catheter

Device: Ballon guide catheter

Guide catheter without balloon

PLACEBO COMPARATOR

Thrombectomy of an acute ischemic stroke using a guide catheter without balloon

Device: Guide catheter without balloon

Interventions

Ballon guide catheter DEVICE

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.

Ballon guide catheter

Guide catheter without balloon DEVICE

Thrombectomy of acute ischemic stroke using a guide catheter without balloon

Guide catheter without balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (7)

• 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.

  PMID: 1792753 BACKGROUND

• 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.

  PMID: 30194109 BACKGROUND

• 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.

  PMID: 32717034 BACKGROUND

• 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.

  PMID: 34280538 BACKGROUND

• 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.

  PMID: 26119323 BACKGROUND

• 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.

  PMID: 30264728 BACKGROUND

• 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.

  PMID: 26898852 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael O Breckwoldt, MD, PhD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Markus Möhlenbruch, MD, PhD

  University Hospital Heidelberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief Immuno-Imaging Neuroradiology

Model Details: Mono-centric, prospective, parallel-group, randomized controlled trial with blinded endpoint evaluation (PROBE design)

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 17, 2026
• Study Start: March 15, 2023
• Primary Completion: July 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)