Trial Outcomes & Findings for NeuroCognition After Carotid Recanalization (NCT NCT04219774)
NCT ID: NCT04219774
Last Updated: 2025-05-09
Results Overview
The MoCA is a screening tool used to assess cognitive function. The possible score range is 0 to 30, with higher scores indicating better cognitive performance.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline, 6 months, 12 months
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
Endovascular Arm
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
6
|
|
Overall Study
6 Weeks Follow-up
|
6
|
0
|
6
|
|
Overall Study
6 Months Follow-up
|
7
|
7
|
6
|
|
Overall Study
12 Months Follow-up
|
6
|
4
|
6
|
|
Overall Study
COMPLETED
|
6
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NeuroCognition After Carotid Recanalization
Baseline characteristics by cohort
| Measure |
Endovascular Arm
n=12 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=13 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=6 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
62 years
n=7 Participants
|
60 years
n=5 Participants
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latino and Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Medical History
Stroke
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Medical History
Current Hypertension
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Medical History
Transient Ischemic Attack
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Medical History
Carotid Artery Disease Surgery
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Medical History
Current COPD
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Medical History
Current Type 2 Diabetes Mellitus
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
MoCA (Montreal Cognitive Assessment) Score
11-15
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
MoCA (Montreal Cognitive Assessment) Score
16-20
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
MoCA (Montreal Cognitive Assessment) Score
21-25
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
MoCA (Montreal Cognitive Assessment) Score
26-29
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Lesion Grade
A
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Lesion Grade
B
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Lesion Grade
C
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Lesion Grade
D
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Lesion Location
Left Internal Carotid Artery
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Lesion Location
Right Internal Carotid Artery
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Lesion Location
Bilateral Internal Carotid Artery
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Participants with data collected at both timepoints for each comparison.
The MoCA is a screening tool used to assess cognitive function. The possible score range is 0 to 30, with higher scores indicating better cognitive performance.
Outcome measures
| Measure |
Endovascular Arm
n=11 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=8 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=4 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score
Baseline to 6 months
|
0.56 score on a scale
Standard Deviation 2.70
|
1.38 score on a scale
Standard Deviation 2.83
|
-0.75 score on a scale
Standard Deviation 1.71
|
|
Change in Montreal Cognitive Assessment (MoCA) Score
Baseline to 12 months
|
0.50 score on a scale
Standard Deviation 2.20
|
-0.80 score on a scale
Standard Deviation 2.86
|
-0.33 score on a scale
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Participants with data collected at both timepoints for each comparison.
This outcome reflects overall cognition. The composite z score is based on average z scores for the tests for each subject (sum of the z scores divided by the number of tests included) from a specifically designed battery of 14 cognitive tests: Montreal Cognitive Assessment (MoCA),Wide Range Achievement Test-5 (WRAT-5); Wechsler Adult Intelligence Scale - IV (WAIS-IV); WAIS-IV, Coding subtest; WAIS-IV, Matrix Reasoning subtest; Hopkins Verbal Learning Test; Benton Visual Retention Test (BVRT); Controlled Oral Word Association (COWA) Test; Boston Naming Test; Boston Diagnostic Aphasia Examination, Complex Ideational Material subtest; Trail-Making Test, part A and part B; Beck Depression Inventory-Fast Screen (BDI-FS); Iowa Scales of Personality Change (ISPC). A Z-score of 0 represents no change. Standard deviations above 0 represent better outcomes; standard deviations below 0 represent worse outcomes.
Outcome measures
| Measure |
Endovascular Arm
n=9 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=8 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=3 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Change in Composite Cognitive Score
Baseline to 6 months
|
0.18 z-score
Standard Deviation 0.63
|
-0.005 z-score
Standard Deviation 0.65
|
0.065 z-score
Standard Deviation 0.88
|
|
Change in Composite Cognitive Score
Baseline to 12 months
|
0.36 z-score
Standard Deviation 0.35
|
0.29 z-score
Standard Deviation 0.76
|
0.26 z-score
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Up to 30 days post procedureOutcome measures
| Measure |
Endovascular Arm
n=12 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=13 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=6 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Number of Participants With Stroke Within 30 Days Post Procedure
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 72 hours post procedureOutcome measures
| Measure |
Endovascular Arm
n=12 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=13 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=6 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Number of Participants With Intracranial Hemorrhage Within 72 Hours Post Procedure
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsOutcome measures
| Measure |
Endovascular Arm
n=12 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=13 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=6 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Number of Participant Deaths
|
1 Participants
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 monthsPopulation: Participants with data collected at both timepoints.
MTT is defined as the average time, in seconds, that circulating blood cells needs to pass within a determinate volume of brain. It is assessed as part of the CT perfusion protocol.
Outcome measures
| Measure |
Endovascular Arm
n=10 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=9 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=3 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Change in Mean Transit Time (MTT) on CT Perfusion
MTT - Left
|
1.15 seconds
Standard Deviation 0.51
|
1.46 seconds
Standard Deviation 0.53
|
1.13 seconds
Standard Deviation 0.1
|
|
Change in Mean Transit Time (MTT) on CT Perfusion
MTT - Right
|
0.60 seconds
Standard Deviation 0.84
|
1.13 seconds
Standard Deviation 0.95
|
1.14 seconds
Standard Deviation NA
Only one participant analyzed
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Participants with data collected at both timepoints.
The change in size of hippocampus in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year.
Outcome measures
| Measure |
Endovascular Arm
n=4 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=4 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=4 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Change in Size of Hippocampus
Hippocampus - Left (baseline to 6 months)
|
-67.54 cm^3
Standard Deviation 80.73
|
27.69 cm^3
Standard Deviation 0
|
49.08 cm^3
Standard Deviation 193.34
|
|
Change in Size of Hippocampus
Hippocampus - Left (baseline to 12 months)
|
-69.00 cm^3
Standard Deviation 54.51
|
-35.79 cm^3
Standard Deviation 78.42
|
-77.62 cm^3
Standard Deviation 89.9
|
|
Change in Size of Hippocampus
Hippocampus - Right (baseline to 6 months)
|
-54.92 cm^3
Standard Deviation 81.52
|
44.55 cm^3
Standard Deviation 0
|
43.05 cm^3
Standard Deviation 161.94
|
|
Change in Size of Hippocampus
Hippocampus - Right (baseline to 12 months)
|
-102.30 cm^3
Standard Deviation 123.80
|
-22.00 cm^3
Standard Deviation 45.24
|
-83.44 cm^3
Standard Deviation 47.86
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Participants with data collected at both timepoints.
The change in size of amygdala in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year.
Outcome measures
| Measure |
Endovascular Arm
n=4 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=4 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=4 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Change in Size of Amygdala
Amydala - Left (baseline to 6 months)
|
-26.47 cm^3
Standard Deviation 60.02
|
33.89 cm^3
Standard Deviation 0
|
14.22 cm^3
Standard Deviation 19.74
|
|
Change in Size of Amygdala
Amydala - Left (baseline to 12 months)
|
-29.36 cm^3
Standard Deviation 52.95
|
2.85 cm^3
Standard Deviation 34.39
|
-3.18 cm^3
Standard Deviation 5.68
|
|
Change in Size of Amygdala
Amydala - Right (baseline to 6 months)
|
-5.76 cm^3
Standard Deviation 22.27
|
-0.64 cm^3
Standard Deviation 0
|
10.96 cm^3
Standard Deviation 24.65
|
|
Change in Size of Amygdala
Amydala - Right (baseline to 12 months)
|
-15.33 cm^3
Standard Deviation 6.61
|
-2.26 cm^3
Standard Deviation 18.16
|
-9.72 cm^3
Standard Deviation 15.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Participants with data collected at each timepoint.
Presence of lactate determined by MRI spectroscopy in centrum semiovale in the ipsilateral side of chronic occlusion of the internal carotid artery (COICA).
Outcome measures
| Measure |
Endovascular Arm
n=7 Participants
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=6 Participants
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=4 Participants
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Number of Participants With the Presence of Lactate on 1H-MRI Spectroscopy
Baseline
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With the Presence of Lactate on 1H-MRI Spectroscopy
6 months
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Presence of Lactate on 1H-MRI Spectroscopy
12 months
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Endovascular Arm
Serious events: 6 serious events
Other events: 10 other events
Deaths: 1 deaths
Medical Arm
Serious events: 6 serious events
Other events: 8 other events
Deaths: 1 deaths
Observational Arm
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Endovascular Arm
n=12 participants at risk
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=13 participants at risk
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=6 participants at risk
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Acute blood loss anemia
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
Acute systolic heart failure
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Investigations
EVD malfunction
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Nervous system disorders
Expressive Aphasia
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Femoral Pseudoaneurysm
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Nervous system disorders
Hydrocephalus
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
Infarct
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
Intraparenchymal hemorrhage
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Myelodysplastic Syndrome
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Perinephric hematoma
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Posterior vitreous hemorrhage
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Regressed neovascularization
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Retroperitoneal hematoma
|
8.3%
1/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Renal and urinary disorders
Stage 4 Urothelial cancer
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
LICA
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Gastrointestinal disorders
Small bowel and Cecal AVM
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
Subacute Chronic Infarcts
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Subarachnoid hemorrhage
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Nervous system disorders
Tonic Clonic Seizures
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Nervous system disorders
Subclinical seizures
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Surgical and medical procedures
Colon Re-section
|
0.00%
0/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
16.7%
1/6 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung mass
|
0.00%
0/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
16.7%
1/6 • Up to 12 months
|
|
General disorders
Mechanical Fall and Facial T
|
0.00%
0/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
16.7%
1/6 • Up to 12 months
|
|
General disorders
Syncopal Fall
|
0.00%
0/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
16.7%
1/6 • Up to 12 months
|
Other adverse events
| Measure |
Endovascular Arm
n=12 participants at risk
Subjects meet all inclusion criteria and were randomized to intervention
Endovascular intervention: Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
|
Medical Arm
n=13 participants at risk
Subjects meet all inclusion criteria and were randomized to best medical management
Aspirin and Clopidogrel (maximal medical Therapy): Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
|
Observational Arm
n=6 participants at risk
Participants without increased MTT or TPP on CTP may still be included in the unrandomized prospective observational arm.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Acute blood loss anemia
|
33.3%
4/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Psychiatric disorders
Altered mental status
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/12 • Up to 12 months
|
15.4%
2/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Gastrointestinal disorders
Bloody Stool
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
General disorders
Carpal Tunnel
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Psychiatric disorders
Cognitive Impairment
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Psychiatric disorders
Decreased Mood
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Endocrine disorders
Diabetes Miletus
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Investigations
Disorientation with Physical Effort
|
16.7%
2/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
Dissection of ECA
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
General disorders
Dysphasia
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
General disorders
Easy Bruising
|
33.3%
4/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Excessive Bleeding
|
33.3%
4/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
General disorders
Fatigue
|
16.7%
2/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Head trauma due to falls
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
General disorders
Headache
|
16.7%
2/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Hematuria
|
8.3%
1/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
High Blood Pressure
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
Hypotension
|
33.3%
4/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Blood and lymphatic system disorders
Lactic acidosis
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Psychiatric disorders
Memory Impairment
|
8.3%
1/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
Myocardial Injury
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
General disorders
Nose Bleeds
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Psychiatric disorders
Progressive Cognitive Impairment
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Psychiatric disorders
Psychiatric Episode
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Nervous system disorders
Severe Anomia
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Cardiac disorders
Transfusion Associated Circulatory Overload
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
0.00%
0/12 • Up to 12 months
|
7.7%
1/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Eye disorders
Visual Field Deficit
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
General disorders
Wrist Hematoma
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
General disorders
Swelling in bilateral lower extremities
|
8.3%
1/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Distal Interphalangeal Fract
|
0.00%
0/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
16.7%
1/6 • Up to 12 months
|
|
Cardiac disorders
Essential Hypertension
|
0.00%
0/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
16.7%
1/6 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder Arthralgias
|
0.00%
0/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
16.7%
1/6 • Up to 12 months
|
|
Eye disorders
Vision Changes
|
0.00%
0/12 • Up to 12 months
|
0.00%
0/13 • Up to 12 months
|
16.7%
1/6 • Up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place