Brief Summary

Rationale and Relevance:

Branch Atheromatous Disease (BAD) describes an atherosclerotic occlusion of one of the deep penetrating cerebral arteries, including the lenticulostriate artery (LSA), paramedian pontine artery (PPA), and anterior choroidal artery (ACHA). BAD is frequently associated with early neurological deterioration (END), particularly progressive motor deficits that contribute to increased disability. Despite its clinical relevance, BAD remains underrepresented in major radiomorphological classification systems such as TOAST, which has led to limited evidence and unclear treatment strategies. Previous studies suggest that the efficacy of intravenous thrombolysis (IVT) may be reduced in BAD compared to other stroke etiologies.

Objectives:

The primary objective of this study is to evaluate the efficacy and safety of IVT compared with single antiplatelet therapy (SAPT) and dual antiplatelet therapy (DAPT) in patients with BAD-related stroke. A secondary objective is to examine the impact of acute-phase blood pressure fluctuations on END and functional neurological outcomes.

Design and Methods:

This international multicenter study will be conducted retrospectively according to the STROBE guidelines. Eligible patients include those with BAD-related stroke treated at one of the participating centers between 2010 and 2025. Inclusion criteria comprise characteristic diffusion-weighted MRI patterns in predefined vascular territories (LSA, PPA, ACHA) and a symptom onset ≤24 hours before admission. Patients with typical lacunar infarcts or with other identified stroke etiologies will be excluded.

Endpoints:

Primary endpoints include functional outcome at three months, defined as a favorable outcome with a modified Rankin Scale score of 0-1; occurrence of END, defined as a ≥4-point worsening on the NIHSS within 24-48 hours; and symptomatic intracerebral hemorrhage. Collected data include clinical, imaging, and therapeutic variables, as well as blood pressure trajectories and pre-stroke treatments (as detailed in the study protocol).

Statistical Analysis:

Analyses will be performed using SPSS and R. Descriptive statistics, univariate analyses, and multivariable models (IPTW and Poisson regression) will be applied. Results will be reported as adjusted relative risks with 95% confidence intervals.

Significance:

This study will provide the first comprehensive evaluation of IVT versus SAPT/DAPT in BAD-related stroke, and will investigate the clinical impact of blood pressure changes in this specific stroke subtype. The findings aim to support evidence-based treatment recommendations for a currently underrecognized and poorly understood stroke etiology.

Conditions

• Stroke
• Thrombolysis
• DAPT(Dual Antiplatelet Therapy)
• SAPT(Single Antiplatelet Therapy)
• Acute Ischemic Stroke

Primary Outcome Measures

• Favorable outcome (mRS 0-1) at three months. (Three months after acute ischemic stroke treatment)
  Modified Rankin Scale (mRS) score at three months, with a favorable outcome defined as mRS 0-1 at three months.
• Early neurological deterioration within 24-48 hours after symptom onset (within 24-48 hours after acute ischemic stroke onset)
  Early neurological deterioration (END), defined as a worsening of the NIHSS score by ≥4 points within 24-48 hours after symptom onset.
• Occurrence of symptomatic intracerebral hemorrhage. (within three months after acute ischemic stroke treatment.)
  Occurrence of symptomatic intracerebral hemorrhage within three months after acute ischemic stroke treatment.

Countries

Austria, Germany, Switzerland

Locations and Investigators

• Clinic Favoriten, Vienna, Austria (Recruiting)
  • Christoph Kirchstetter, Dr.
• Clinic Hietzing, Vienna, Austria (Recruiting)
  • Vera Kopfer, Dr.
• Department of Neurology, St. John's Hospital, Vienna, Austria, Vienna, Austria (Recruiting)
  • Julian Frederic Hotz, DDr.
  • Marek Sykora, Prof. Dr.
• Department of Neurology, Medical University of Vienna, Vienna, Austria (Recruiting)
  • Stefan Greisenegger, Prof. Dr.
• Department of Neurology, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin, Germany (Not yet recruiting)
  • Christian Nolte, Prof. Dr.
• Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany (Recruiting)
  • Jan Purrucker, Prof. Dr.
• Department of Neurology & Stroke, University of Tübingen, Tübingen, Germany (Recruiting)
  • Sven Poli, Prof. Dr.
• Department of Neurology, Universityhospital of Bern, Bern, Switzerland (Not yet recruiting)
  • Julian Frederic Hotz, DDr.

Study Officials

• Julian Frederic Hotz, DDr. (Principal Investigator) — 1. Department of Neurology, St. John's Hospital, Vienna, Austria, 2. Department of Neurology, University Hospital, Bern, Switzerland, 3. Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna
• Marek Sykora, Prof. Dr. (Principal Investigator) — 1. Sigmund Freud University Vienna, Austria, 2. Department of Neurology, St. John's Hospital, Vienna, Austria