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All trials for Ischemic Stroke All trials for Intracranial Hematoma All trials of Mechanical thrombectomy All trials of Minimally invasive surgery
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Patients with ischemic stroke | | Device: Mechanical thrombectomy | |
| Patients with intracranial hematoma | | Other: Minimally invasive surgery | |
- Mechanical thrombectomy (Device): 1. Clot specimen collection
2. Extracranial blood collection
- Minimally invasive surgery (Other): 1. Clot specimen collection
2. Arterial blood collection
+Outcome measures
Primary outcomes
- Clot Specimen Histology [Clot specimen obtained during procedure]: Numbers of clot specimen for histology analysis
- Blood and Clot Specimen Transcriptomics [Blood and clot specimen obtained during procedure]: Numbers of blood and clot for RNA sequency. Only includes successful sample number that was processed.
- Blood and Clot Specimen Proteomics [Blood and clot specimen obtained during procedure]: Numbers of blood and clot specimen for proteomic analysis
- Blood and Clot Specimen Genomics [Blood and clot specimen obtained during procedure]: Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs). Only includes successful sample number that was processed.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Posted results
Participant flow
| Milestone | Patients With Ischemic Stroke | Patients With Intracranial Hematoma |
|---|
| Started | 388 | 12 |
| Completed | 388 | 12 |
| Not completed | 0 | 0 |
Outcome results
- Clot Specimen Histology (Primary), Number, Count of specimen: Patients With Ischemic Stroke 373; Patients With Intracranial Hematoma 12
- Blood and Clot Specimen Transcriptomics (Primary), Number, Count of specimen: Patients With Ischemic Stroke 341; Patients With Intracranial Hematoma 9
- Blood and Clot Specimen Proteomics (Primary), Number, Count of specimen: Patients With Ischemic Stroke 351; Patients With Intracranial Hematoma 12
- Blood and Clot Specimen Genomics (Primary), Number, Count of specimen: Patients With Ischemic Stroke 387; Patients With Intracranial Hematoma 12
Adverse events
Time frame: Adverse events were collected through 7 days post-procedure.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Patients With Ischemic Stroke | 86/388 (22.2%) | 38/165 (23.0%) | 11/165 (6.7%) |
| Patients With Intracranial Hematoma | 3/12 (25.0%) | 0 | 0 |
Serious adverse events by term
| Term | Organ system | Patients With Ischemic Stroke | Patients With Intracranial Hematoma |
|---|
| Symptomatic ICH | Nervous system disorders | 4/165 | 0/0 |
| Acute Ischemic Stroke | Nervous system disorders | 5/165 | 0/0 |
| Hemorrhagic Stroke | Nervous system disorders | 1/165 | 0/0 |
| Progression of Index Stroke | Nervous system disorders | 13/165 | 0/0 |
| New or Worsening Neurological Deficit | Nervous system disorders | 3/165 | 0/0 |
| Pneumonia | Infections and infestations | 5/165 | 0/0 |
| Other | Investigations | 7/165 | 0/0 |
Other adverse events by term
| Term | Organ system | Patients With Ischemic Stroke | Patients With Intracranial Hematoma |
|---|
| Anemia | Blood and lymphatic system disorders | 1/165 | 0/0 |
| Progression of Index Stroke | Nervous system disorders | 3/165 | 0/0 |
| Asymptomatic ICH | Nervous system disorders | 5/165 | 0/0 |
| Asymptomatic Petechial Hemorrhage | Nervous system disorders | 2/165 | 0/0 |
+Locations (27)
| Facility | City | Country | Status |
|---|
| Banner Desert Medical Center | Mesa, Arizona | United States | |
| Banner University Medical Center - Phoenix | Phoenix, Arizona | United States | |
| Christiana Care | Newark, Delaware | United States | |
| George Washington University | Washington D.C., District of Columbia | United States | |
| Baptist Medical Center | Jacksonville, Florida | United States | |
| Northwestern University | Chicago, Illinois | United States | |
| Indiana University Health Methodist Hospital | Indianapolis, Indiana | United States | |
| University of Kentucky | Lexington, Kentucky | United States | |
| Norton Neuroscience Institute | Louisville, Kentucky | United States | |
| MaineHealth | Portland, Maine | United States | |
| Adventist Healthcare Shady Grove Medical Center | Rockville, Maryland | United States | |
| Massachusetts General Hospital | Boston, Massachusetts | United States | |
| Metro Health | Wyoming, Michigan | United States | |
| St. Dominic Jackson Memorial Hospital | Jackson, Mississippi | United States | |
| SSM St. Clare Healthcare | Fenton, Missouri | United States | |
| Mount Sinai | New York, New York | United States | |
| Stony Brook University | Stony Brook, New York | United States | |
| Westchester Medical Center | Valhalla, New York | United States | |
| Miami Valley Hospital | Dayton, Ohio | United States | |
| University of Pennsylvania | Philadelphia, Pennsylvania | United States | |
| Greenville Memorial / Prisma Health | Greenville, South Carolina | United States | |
| Fort Sanders Regional Medical Center | Knoxville, Tennessee | United States | |
| Methodist University | Memphis, Tennessee | United States | |
| University of Texas Health Center, Memorial Hermann Medical Center | Houston, Texas | United States | |
| Virginia Commonwealth University | Richmond, Virginia | United States | |
| Swedish Health Services, Swedish Cherry Hill | Seattle, Washington | United States | |
| Tacoma General Hosptial | Tacoma, Washington | United States | |
+Publications
- Results publication: Branscom GA, Seah C, Som T, Vicari J, Dabney AR, Baltan S, Sohrabji F, Pennypacker K, Woodward KB, Rapoport BI, Schulman S, Fraser JF, Kellner CP. Using clinical and thrombus characteristics to predict the etiology of ischemic stroke: An analysis of the INSIGHT registry. J Stroke Cerebrovasc Dis. 2026 Jul;35(7):108665. doi: 10.1016/j.jstrokecerebrovasdis.2026.108665. Epub 2026 May 19. PMID 42155823
+Study documents