Trial Outcomes & Findings for The Capillary Index Score Trial (NCT NCT02618031)
NCT ID: NCT02618031
Last Updated: 2020-02-05
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
90 days
Results posted on
2020-02-05
Participant Flow
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.
Participant milestones
| Measure |
Favorable CIS
Patients with a favorable CIS (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 tPA directly at the site of the clot.
|
Poor CIS
Patients with a poor CIS (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 tPA directly at the site of the clot.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
11
|
|
Overall Study
COMPLETED
|
45
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Capillary Index Score Trial
Baseline characteristics by cohort
| Measure |
Favorable CIS
n=46 Participants
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.
|
Poor CIS
n=11 Participants
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.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=99 Participants
|
73 years
n=107 Participants
|
70 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Height
|
165 cm
STANDARD_DEVIATION 14 • n=99 Participants
|
171 cm
STANDARD_DEVIATION 6 • n=107 Participants
|
166 cm
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Weight
|
82 kg
STANDARD_DEVIATION 25 • n=99 Participants
|
95 kg
STANDARD_DEVIATION 20 • n=107 Participants
|
85 kg
STANDARD_DEVIATION 24 • n=206 Participants
|
|
diabetes
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
blood pressure
|
147 mm Hg
STANDARD_DEVIATION 32 • n=99 Participants
|
156 mm Hg
STANDARD_DEVIATION 32 • n=107 Participants
|
149 mm Hg
STANDARD_DEVIATION 32 • n=206 Participants
|
|
occlusion site
middle cerebral artery (MCA)
|
31 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
occlusion site
internal carotid artery (ICA)
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
occlusion site
combination
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
ischemic site
MCA
|
41 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
ischemic site
ICA
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
ischemic site
combination
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
National Institutes of Health stroke scale
|
17 units on a scale
STANDARD_DEVIATION 5 • n=99 Participants
|
21 units on a scale
STANDARD_DEVIATION 7 • n=107 Participants
|
18 units on a scale
STANDARD_DEVIATION 6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: A good outcome is defined as mRS 0-2
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).
Outcome measures
| Measure |
Favorable CIS
n=45 Participants
Patients with a favorable CIS (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 tPA directly at the site of the clot.
|
Poor CIS
n=11 Participants
Patients with a poor CIS (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 tPA directly at the site of the clot.
|
Favorable CIS and Poor Revascularization
Patients with a favorable CIS (fCIS) who achieve poor revascularization based on modified treatment in cerebral infarction (mTICI) score of 0, 1, or 2A
Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
|
Poor CIS and Poor Revascularization
Patients with a poor CIS (pCIS) who achieve poor revascularization based on modified treatment in cerebral infarction (mTICI) score of 0, 1, or 2A
Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
|
|---|---|---|---|---|
|
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
mRS 0-2
|
22 Participants
|
1 Participants
|
—
|
—
|
|
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
mRS 3-6
|
23 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 day - 1 weekPopulation: post-operative bleeding was not available for two subjects who died before a postoperative scan
Complication : Clinically relevant intracranial hemorrhage and vasogenic edema as defined by parenchymal hematoma (PH) 1 or 2
Outcome measures
| Measure |
Favorable CIS
n=45 Participants
Patients with a favorable CIS (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 tPA directly at the site of the clot.
|
Poor CIS
n=10 Participants
Patients with a poor CIS (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 tPA directly at the site of the clot.
|
Favorable CIS and Poor Revascularization
Patients with a favorable CIS (fCIS) who achieve poor revascularization based on modified treatment in cerebral infarction (mTICI) score of 0, 1, or 2A
Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
|
Poor CIS and Poor Revascularization
Patients with a poor CIS (pCIS) who achieve poor revascularization based on modified treatment in cerebral infarction (mTICI) score of 0, 1, or 2A
Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
|
|---|---|---|---|---|
|
Complication Rate Between Favorable CIS Group Versus Poor CIS Group
PH 1 or 2
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Complication Rate Between Favorable CIS Group Versus Poor CIS Group
no PH1 or 2
|
44 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 90 daysPopulation: output = number of patients with a good outcome one patient was lost to follow up
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
Outcome measures
| Measure |
Favorable CIS
n=36 Participants
Patients with a favorable CIS (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 tPA directly at the site of the clot.
|
Poor CIS
n=8 Participants
Patients with a poor CIS (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 tPA directly at the site of the clot.
|
Favorable CIS and Poor Revascularization
n=9 Participants
Patients with a favorable CIS (fCIS) who achieve poor revascularization based on modified treatment in cerebral infarction (mTICI) score of 0, 1, or 2A
Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
|
Poor CIS and Poor Revascularization
n=3 Participants
Patients with a poor CIS (pCIS) who achieve poor revascularization based on modified treatment in cerebral infarction (mTICI) score of 0, 1, or 2A
Following endovascular treatment (EVT), revascularization was graded based on the mTICI classification according to:
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2A: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2B: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
|
|---|---|---|---|---|
|
Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.
Good outcome
|
19 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.
Poor outcome
|
17 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
Adverse Events
Favorable CIS
Serious events: 1 serious events
Other events: 2 other events
Deaths: 8 deaths
Poor CIS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Favorable CIS
n=45 participants at risk
Patients with a favorable CIS (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 tPA directly at the site of the clot.
|
Poor CIS
n=11 participants at risk
Patients with a poor CIS (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 tPA directly at the site of the clot.
|
|---|---|---|
|
Vascular disorders
hemorrhage
|
2.2%
1/45 • Number of events 1 • 3 months
All subjects in the study are considered at risk for death due to the nature of the stroke.
|
0.00%
0/11 • 3 months
All subjects in the study are considered at risk for death due to the nature of the stroke.
|
Other adverse events
| Measure |
Favorable CIS
n=45 participants at risk
Patients with a favorable CIS (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 tPA directly at the site of the clot.
|
Poor CIS
n=11 participants at risk
Patients with a poor CIS (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 tPA directly at the site of the clot.
|
|---|---|---|
|
General disorders
radiation
|
4.4%
2/45 • Number of events 2 • 3 months
All subjects in the study are considered at risk for death due to the nature of the stroke.
|
9.1%
1/11 • Number of events 1 • 3 months
All subjects in the study are considered at risk for death due to the nature of the stroke.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place