N/A N=400

Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Ischemic Stroke · Intracranial Hematoma

Bottom Line

View on ClinicalTrials.gov: NCT04693767 ↗

Enrolled (actual)

400

Serious AEs

23.0%

Results posted

Oct 2024

Primary outcome: Primary: Clot Specimen Histology — 373; 12 Count of specimen

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Mechanical thrombectomy (Device); Minimally invasive surgery (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Penumbra Inc.
Primary completion: Jul 2022

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	—

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.

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

View full record on ClinicalTrials.gov →

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.