N/A
Completed N=400
Investigation of Clot in Ischemic Stroke and Hematoma Evacuation
Stroke · Intracranial Hematoma
Source: ClinicalTrials.gov NCT04693767 ↗
Enrolled (actual)
400
Serious AEs
23.0%
Results posted
Oct 2024
Primary outcomePrimary: Clot Specimen Histology — 373; 12 Count of specimen
Summary
The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clot Specimen Histology |
373; 12 | — |
| PRIMARY Blood and Clot Specimen Transcriptomics |
341; 9; 365; 12 | — |
| PRIMARY Blood and Clot Specimen Proteomics |
351; 12; 366; 12 | — |
| PRIMARY Blood and Clot Specimen Genomics |
387; 12 | — |
Eligibility Criteria
Inclusion Criteria
- ≥ 18 Years of Age
- Frontline treatment with: Penumbra System for ischemic stroke patients eligible for mechanical thrombectomy or Artemis Neuro Evacuation device for intracranial hematoma evacuation in patients eligible for minimally invasive surgery (MIS)
- Extracted thrombus/embolus
- Informed consent is obtained from either the patient or legally authorized representative (LAR)
Exclusion Criteria
- Pregnancy or positive pregnancy test according to site routine practice (only required for women of child bearing potential; serum or urine acceptable)
- Currently participating in an investigational drug or device clinical trial that may confound the ability to capture clot and/or influence clot composition. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
Data sourced from ClinicalTrials.gov (NCT04693767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.