Trial Outcomes & Findings for Investigation of Clot in Ischemic Stroke and Hematoma Evacuation (NCT NCT04693767)
NCT ID: NCT04693767
Last Updated: 2024-10-23
Results Overview
Numbers of clot specimen for histology analysis
Recruitment status
COMPLETED
Target enrollment
400 participants
Primary outcome timeframe
Clot specimen obtained during procedure
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
Patients With Ischemic Stroke
Mechanical thrombectomy
|
Patients With Intracranial Hematoma
Minimally invasive surgery
|
|---|---|---|
|
Overall Study
STARTED
|
388
|
12
|
|
Overall Study
COMPLETED
|
388
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of Clot in Ischemic Stroke and Hematoma Evacuation
Baseline characteristics by cohort
| Measure |
Patients With Ischemic Stroke
n=388 Participants
Mechanical thrombectomy: 1) Clot specimen collection 2) Extracranial blood collection
|
Patients With Intracranial Hematoma
n=12 Participants
Minimally invasive surgery: 1) Clot specimen collection 2) Arterial blood collection
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 14.85 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 11.65 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 14.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
203 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
360 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
73 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
276 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Clot specimen obtained during procedurePopulation: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.
Numbers of clot specimen for histology analysis
Outcome measures
| Measure |
Patients With Ischemic Stroke
n=388 Participants
Clot Histology
|
Patients With Intracranial Hematoma
n=12 Participants
Clot Histology
|
|---|---|---|
|
Clot Specimen Histology
|
373 Count of specimen
|
12 Count of specimen
|
PRIMARY outcome
Timeframe: Blood and clot specimen obtained during procedurePopulation: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.
Numbers of blood and clot for RNA sequency. Only includes successful sample number that was processed.
Outcome measures
| Measure |
Patients With Ischemic Stroke
n=388 Participants
Clot Histology
|
Patients With Intracranial Hematoma
n=12 Participants
Clot Histology
|
|---|---|---|
|
Blood and Clot Specimen Transcriptomics
Clot RNA Analyzed
|
341 Count of specimen
|
9 Count of specimen
|
|
Blood and Clot Specimen Transcriptomics
Blood RNA Analyzed
|
365 Count of specimen
|
12 Count of specimen
|
PRIMARY outcome
Timeframe: Blood and clot specimen obtained during procedurePopulation: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.
Numbers of blood and clot specimen for proteomic analysis
Outcome measures
| Measure |
Patients With Ischemic Stroke
n=388 Participants
Clot Histology
|
Patients With Intracranial Hematoma
n=12 Participants
Clot Histology
|
|---|---|---|
|
Blood and Clot Specimen Proteomics
Clot Protein Analysis
|
351 Count of specimen
|
12 Count of specimen
|
|
Blood and Clot Specimen Proteomics
Blood Protein Analysis
|
366 Count of specimen
|
12 Count of specimen
|
PRIMARY outcome
Timeframe: Blood and clot specimen obtained during procedurePopulation: Total of 388 participants in Ischemic Stroke Cohort and 12 participants in Intracranial Hematoma Cohort.
Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs). Only includes successful sample number that was processed.
Outcome measures
| Measure |
Patients With Ischemic Stroke
n=388 Participants
Clot Histology
|
Patients With Intracranial Hematoma
n=12 Participants
Clot Histology
|
|---|---|---|
|
Blood and Clot Specimen Genomics
|
387 Count of specimen
|
12 Count of specimen
|
Adverse Events
Patients With Ischemic Stroke
Serious events: 38 serious events
Other events: 11 other events
Deaths: 86 deaths
Patients With Intracranial Hematoma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Patients With Ischemic Stroke
n=165 participants at risk
Mechanical thrombectomy: 1) Clot specimen collection 2) Extracranial blood collection
|
Patients With Intracranial Hematoma
Minimally invasive surgery: 1) Clot specimen collection 2) Arterial blood collection
|
|---|---|---|
|
Nervous system disorders
Symptomatic ICH
|
2.4%
4/165 • 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.
|
—
0/0 • 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.
|
|
Nervous system disorders
Acute Ischemic Stroke
|
3.0%
5/165 • 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.
|
—
0/0 • 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.
|
|
Nervous system disorders
Hemorrhagic Stroke
|
0.61%
1/165 • 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.
|
—
0/0 • 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.
|
|
Nervous system disorders
Progression of Index Stroke
|
7.9%
13/165 • 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.
|
—
0/0 • 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.
|
|
Nervous system disorders
New or Worsening Neurological Deficit
|
1.8%
3/165 • 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.
|
—
0/0 • 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.
|
|
Infections and infestations
Pneumonia
|
3.0%
5/165 • 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.
|
—
0/0 • 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.
|
|
Investigations
Other
|
4.2%
7/165 • 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.
|
—
0/0 • 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.
|
Other adverse events
| Measure |
Patients With Ischemic Stroke
n=165 participants at risk
Mechanical thrombectomy: 1) Clot specimen collection 2) Extracranial blood collection
|
Patients With Intracranial Hematoma
Minimally invasive surgery: 1) Clot specimen collection 2) Arterial blood collection
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.61%
1/165 • 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.
|
—
0/0 • 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.
|
|
Nervous system disorders
Progression of Index Stroke
|
1.8%
3/165 • 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.
|
—
0/0 • 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.
|
|
Nervous system disorders
Asymptomatic ICH
|
3.0%
5/165 • 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.
|
—
0/0 • 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.
|
|
Nervous system disorders
Asymptomatic Petechial Hemorrhage
|
1.2%
2/165 • 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.
|
—
0/0 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place