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

NCT07478042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-03-17

No results posted yet for this study

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

Interventions

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.

DEVICE

Guide catheter without balloon

Thrombectomy of acute ischemic stroke using a guide catheter without balloon

Sponsors & Collaborators

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Michael O Breckwoldt, MD, PhD · University Hospital Heidelberg

  • Markus Möhlenbruch, MD, PhD · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2025-07-30
Completion
2025-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07478042 on ClinicalTrials.gov