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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ischemic stroke |
| ||
| Patients with intracranial hematoma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical thrombectomy | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Clot Specimen Histology | Numbers of clot specimen for histology analysis | Clot specimen obtained during procedure |
| Blood and Clot Specimen Transcriptomics | Numbers of blood and clot for RNA sequency. Only includes successful sample number that was processed. | Blood and clot specimen obtained during procedure |
| Blood and Clot Specimen Proteomics | Numbers of blood and clot specimen for proteomic analysis | Blood and clot specimen obtained during procedure |
| Blood and Clot Specimen Genomics | Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs). Only includes successful sample number that was processed. | Blood and clot specimen obtained during procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing either ischemic stroke thrombectomy procedures or minimally invasive interventions for intracranial hematoma evacuation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Desert Medical Center | Mesa | Arizona | 85202 | United States | ||
| Banner University Medical Center - Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42155823 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Ischemic Stroke | Mechanical thrombectomy |
| FG001 | Patients With Intracranial Hematoma | Minimally invasive surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2022 |
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Clot and blood specimen
| Minimally invasive surgery | Other |
|
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| Phoenix |
| Arizona |
| 85006 |
| United States |
| Christiana Care | Newark | Delaware | 19713 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Baptist Medical Center | Jacksonville | Florida | 32207 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Norton Neuroscience Institute | Louisville | Kentucky | 40241 | United States |
| MaineHealth | Portland | Maine | 04012 | United States |
| Adventist Healthcare Shady Grove Medical Center | Rockville | Maryland | 20850 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Metro Health | Wyoming | Michigan | 49519 | United States |
| St. Dominic Jackson Memorial Hospital | Jackson | Mississippi | 39216 | United States |
| SSM St. Clare Healthcare | Fenton | Missouri | 63026 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Greenville Memorial / Prisma Health | Greenville | South Carolina | 29605 | United States |
| Fort Sanders Regional Medical Center | Knoxville | Tennessee | 37916 | United States |
| Methodist University | Memphis | Tennessee | 38104 | United States |
| University of Texas Health Center, Memorial Hermann Medical Center | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Swedish Health Services, Swedish Cherry Hill | Seattle | Washington | 98122 | United States |
| Tacoma General Hosptial | Tacoma | Washington | 98405 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Ischemic Stroke | Mechanical thrombectomy: 1) Clot specimen collection 2) Extracranial blood collection |
| BG001 | Patients With Intracranial Hematoma | Minimally invasive surgery: 1) Clot specimen collection 2) Arterial blood collection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clot Specimen Histology | Numbers of clot specimen for histology analysis | Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort. | Posted | Number | Count of specimen | Clot specimen obtained during procedure |
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| |||||||||||||||||||||||||||||
| Primary | Blood and Clot Specimen Transcriptomics | Numbers of blood and clot for RNA sequency. Only includes successful sample number that was processed. | Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort. | Posted | Number | Count of specimen | Blood and clot specimen obtained during procedure |
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| Primary | Blood and Clot Specimen Proteomics | Numbers of blood and clot specimen for proteomic analysis | Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort. | Posted | Number | Count of specimen | Blood and clot specimen obtained during procedure |
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| ||||||||||||||||||||||||||||||
| Primary | Blood and Clot Specimen Genomics | Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs). Only includes successful sample number that was processed. | Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort. | Posted | Number | Count of specimen | Blood and clot specimen obtained during procedure |
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Adverse events were collected through 7 days post-procedure.
Adverse Event (AE): any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in participants, whether anticipated or unanticipated. As was pre-specified in the study protocol, only participants with Ischemic Stroke, who were treated with a RED Reperfusion Catheter (N=165), were assessed for serious and other adverse events. The RED Reperfusion Catheter was not a treatment option for participants with Intracranial Hematoma.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Ischemic Stroke | Mechanical thrombectomy: 1) Clot specimen collection 2) Extracranial blood collection | 86 | 388 | 38 | 165 | 11 | 165 |
| EG001 | Patients With Intracranial Hematoma | Minimally invasive surgery: 1) Clot specimen collection 2) Arterial blood collection | 3 | 12 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptomatic ICH | Nervous system disorders | Non-systematic Assessment |
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| Acute Ischemic Stroke | Nervous system disorders | Non-systematic Assessment |
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| Hemorrhagic Stroke | Nervous system disorders | Non-systematic Assessment |
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| Progression of Index Stroke | Nervous system disorders | Non-systematic Assessment |
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| New or Worsening Neurological Deficit | Nervous system disorders | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Other | Investigations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Progression of Index Stroke | Nervous system disorders | Non-systematic Assessment |
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| Asymptomatic ICH | Nervous system disorders | Non-systematic Assessment |
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| Asymptomatic Petechial Hemorrhage | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brooke Lawson | Penumbra Inc. | +15109952183 | blawson@penumbrainc.com |
| Aug 15, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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