Acute Stroke, Brain Ischemia, Ischemic Stroke
Conditions
Keywords
capillary index score, acute ischemic stroke, collateral circulation, cerebral ischemia, diagnostic imaging
Brief summary
This study seeks to investigate the capillary index score (CIS) to further improve patient selection of endovascular treatment (EVT) in acute ischemic stroke (AIS). The hypothesis or idea being tested: Patients with favorable CIS who are successfully revascularized with EVT can have successful outcomes with an extended time window for treatment.
Detailed description
This study is trying to look at how the well-being of the patient following treatment is influenced by peripheral blood supply (collateral flow) to the area lacking primary blood flow due to the clot. Treatment of AIS includes EVT and medical treatment. EVT is typically not offered to patients after 6 hours of the onset of symptoms. The current study is based on the belief that patients can be successfully treated with the EVT up to 8 hours, as long as they have good peripheral blood flow (collateral flow) to the area of tissue blocked of the primary blood supply. The study will evaluate the ability of the capillar index score (CIS) to identify patients who can be successfully treated with EVT. The CIS quantifies blood supply to the ischemic area from peripheral vessels (collateral flow) based on diagnostic cerebral angiogram. Patients are graded on a scale from 0-3, with 0 and 1 considered a poor CIS (pCIS) and 2 and 3 considered a favorable CIS (fCIS). All patients will be treated with EVT and medical treatment consistent with national guidelines. The primary endpoint is the clinical outcome at 90 days between fCIS group versus pCIS group. The secondary endpoint is the influence of successful revascularization on outcomes for patients with fCIS or pCIS.
Interventions
PROCEDUREEndovascular Treatment (EVT)
EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA (tissue plasminogen activator) directly at the site of the clot. The protocol calls for use of the Trevo stent retriever (Stryker Neurovascular) for the first pass of clot removal.
Sponsors
Stryker Neurovascular
Rochester General Hospital
University of Vermont Medical Center
University of North Carolina, Chapel Hill
NYU Langone Health
WellStar Health System
Firas Al-Ali
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participants and investigators evaluating 90 day outcomes will be blinded to the group.
Intervention model description
Patients will be assigned to one of two groups based on the outcome of diagnostic evaluation. Treatment will be identical for the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (M1) 2. Within 24 hours of onset of symptoms 3. NIHSS Score is 8 or greater
Exclusion criteria
1. Contra-indication for IAT found on initial CT 2. Intracranial hemorrhage 3. Stroke mimics (tumor, herpetic encephalitis, etc.) 4. More than 1/3 hypodensity on non-enhanced head CT prior to intervention 5. ASPECT Score less than 6 6. Pre-existing disability defined as modified Rankin Scale (mRS) score more than 2 7. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group. | 90 days | The mRS Score ranges from 0-6 and describes the degree of disability or dependence after a stroke. The grades are no symptoms (0), no significant disability (1), slight disability (2), moderate disability (3), moderately severe disability (4), severe disability (5), and death (6). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate Between Favorable CIS Group Versus Poor CIS Group | 1 day - 1 week | Complication : Clinically relevant intracranial hemorrhage and vasogenic edema as defined by parenchymal hematoma (PH) 1 or 2 |
| Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | 90 days | Revascularization status will be classified as poor (mTICI = 0-2A) or good (mTICI = 2B, 3). Rate of good clinical outcomes between groups will be compared based on the combination of CIS and revascularization status. Good outcome will be measured based on the modified Rankin scale score according to: 0: No symptoms 1. No significant disability despite symptoms 2. Slight disability 3. Moderate disability 4. Moderately severe disability 5. Severe disability 6. Dead A score of 0-2 is considered a good outcome |
Countries
United States
Participant flow
Pre-assignment details
Final assignment to a group was not determined until the diagnostic cerebral angiograms were evaluated by the core lab at the end of the study to quantify the Capillary Index Score for each subject. Preliminary assessment of group was determined by the operators at the time of treatment.
Participants by arm
| Arm | Count |
|---|---|
| Favorable CIS Patients with a favorable Capillary Index Score (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.
Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tissue plasminogen activator (tPA) directly at the site of the clot. | 46 |
| Poor CIS Patients with a poor Capillary Index Score (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.
Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tissue plasminogen activator (tPA) directly at the site of the clot. | 11 |
| Total | 57 |
Baseline characteristics
| Characteristic | Favorable CIS | Poor CIS | Total |
|---|---|---|---|
| Age, Continuous | 70 years | 73 years | 70 years |
| blood pressure | 147 mm Hg STANDARD_DEVIATION 32 | 156 mm Hg STANDARD_DEVIATION 32 | 149 mm Hg STANDARD_DEVIATION 32 |
| diabetes | 7 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 11 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 165 cm STANDARD_DEVIATION 14 | 171 cm STANDARD_DEVIATION 6 | 166 cm STANDARD_DEVIATION 13 |
| ischemic site combination | 4 Participants | 4 Participants | 8 Participants |
| ischemic site ICA | 1 Participants | 1 Participants | 2 Participants |
| ischemic site MCA | 41 Participants | 6 Participants | 47 Participants |
| National Institutes of Health stroke scale | 17 units on a scale STANDARD_DEVIATION 5 | 21 units on a scale STANDARD_DEVIATION 7 | 18 units on a scale STANDARD_DEVIATION 6 |
| occlusion site combination | 13 Participants | 6 Participants | 19 Participants |
| occlusion site internal carotid artery (ICA) | 2 Participants | 1 Participants | 3 Participants |
| occlusion site middle cerebral artery (MCA) | 31 Participants | 4 Participants | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 9 Participants | 50 Participants |
| Region of Enrollment United States | 46 Participants | 11 Participants | 57 Participants |
| Sex: Female, Male Female | 33 Participants | 7 Participants | 40 Participants |
| Sex: Female, Male Male | 13 Participants | 4 Participants | 17 Participants |
| Weight | 82 kg STANDARD_DEVIATION 25 | 95 kg STANDARD_DEVIATION 20 | 85 kg STANDARD_DEVIATION 24 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 45 | 7 / 11 |
| other Total, other adverse events | 2 / 45 | 1 / 11 |
| serious Total, serious adverse events | 1 / 45 | 0 / 11 |
Outcome results
Primary
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
The mRS Score ranges from 0-6 and describes the degree of disability or dependence after a stroke. The grades are no symptoms (0), no significant disability (1), slight disability (2), moderate disability (3), moderately severe disability (4), severe disability (5), and death (6).
Time frame: 90 days
Population: A good outcome is defined as mRS 0-2
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Favorable CIS | Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group. | mRS 0-2 | 22 Participants |
| Favorable CIS | Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group. | mRS 3-6 | 23 Participants |
| Poor CIS | Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group. | mRS 0-2 | 1 Participants |
| Poor CIS | Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group. | mRS 3-6 | 10 Participants |
Secondary
Complication Rate Between Favorable CIS Group Versus Poor CIS Group
Complication : Clinically relevant intracranial hemorrhage and vasogenic edema as defined by parenchymal hematoma (PH) 1 or 2
Time frame: 1 day - 1 week
Population: post-operative bleeding was not available for two subjects who died before a postoperative scan
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Favorable CIS | Complication Rate Between Favorable CIS Group Versus Poor CIS Group | PH 1 or 2 | 1 Participants |
| Favorable CIS | Complication Rate Between Favorable CIS Group Versus Poor CIS Group | no PH1 or 2 | 44 Participants |
| Poor CIS | Complication Rate Between Favorable CIS Group Versus Poor CIS Group | PH 1 or 2 | 4 Participants |
| Poor CIS | Complication Rate Between Favorable CIS Group Versus Poor CIS Group | no PH1 or 2 | 6 Participants |
Secondary
Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.
Revascularization status will be classified as poor (mTICI = 0-2A) or good (mTICI = 2B, 3). Rate of good clinical outcomes between groups will be compared based on the combination of CIS and revascularization status. Good outcome will be measured based on the modified Rankin scale score according to: 0: No symptoms 1. No significant disability despite symptoms 2. Slight disability 3. Moderate disability 4. Moderately severe disability 5. Severe disability 6. Dead A score of 0-2 is considered a good outcome
Time frame: 90 days
Population: output = number of patients with a good outcome one patient was lost to follow up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Favorable CIS | Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | Good outcome | 19 Participants |
| Favorable CIS | Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | Poor outcome | 17 Participants |
| Poor CIS | Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | Poor outcome | 7 Participants |
| Poor CIS | Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | Good outcome | 1 Participants |
| Favorable CIS and Poor Revascularization | Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | Good outcome | 3 Participants |
| Favorable CIS and Poor Revascularization | Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | Poor outcome | 6 Participants |
| Poor CIS and Poor Revascularization | Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | Good outcome | 0 Participants |
| Poor CIS and Poor Revascularization | Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | Poor outcome | 3 Participants |