Trial Outcomes & Findings for Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting (NCT NCT01654666)
NCT ID: NCT01654666
Last Updated: 2015-11-11
Results Overview
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
Within six months after carotid artery stenting
Results posted on
2015-11-11
Participant Flow
Symptomatic and asymptomatic subjects with carotid artery stenosis which was more than 70% by angiography , duplex ultrasound, Computed Tomography Angiography or Magnetic Resonance Angiography (NASCET criteria), who could undergo carotid artery stenting and all follow-ups, were recruited starting from August 2012.
Participant milestones
| Measure |
RIPC Group
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
63
|
|
Overall Study
Primary Analysis
|
52
|
56
|
54
|
|
Overall Study
COMPLETED
|
48
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
14
|
Reasons for withdrawal
| Measure |
RIPC Group
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
7
|
4
|
8
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
1
|
Baseline Characteristics
Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Baseline characteristics by cohort
| Measure |
RIPC Group
n=63 Participants
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
n=63 Participants
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
n=63 Participants
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.49 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
66.47 years
STANDARD_DEVIATION 8.54 • n=7 Participants
|
65.71 years
STANDARD_DEVIATION 8.61 • n=5 Participants
|
66.56 years
STANDARD_DEVIATION 8.58 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Han race
|
63 participants
n=5 Participants
|
63 participants
n=7 Participants
|
63 participants
n=5 Participants
|
189 participants
n=4 Participants
|
|
Pre-treatment scans
New DWI lesions
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Pre-treatment scans
No new DWI lesions
|
61 participants
n=5 Participants
|
61 participants
n=7 Participants
|
62 participants
n=5 Participants
|
184 participants
n=4 Participants
|
|
Clinical manifestation
Symptomatic
|
41 participants
n=5 Participants
|
45 participants
n=7 Participants
|
42 participants
n=5 Participants
|
128 participants
n=4 Participants
|
|
Clinical manifestation
Asymptomatic
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
21 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Contralateral carotid condition
Severe stenosis
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Contralateral carotid condition
Occlusion
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Contralateral carotid condition
Other
|
56 participants
n=5 Participants
|
57 participants
n=7 Participants
|
57 participants
n=5 Participants
|
170 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within six months after carotid artery stentingPopulation: The analysis population only included participants who fully completed the study.
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.
Outcome measures
| Measure |
RIPC Group
n=48 Participants
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
n=50 Participants
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
n=49 Participants
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.
Ischemic stroke within 6 months
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.
TIA within 6 months
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.
No cerebrovascular event within 6 months
|
47 participants
|
48 participants
|
46 participants
|
|
Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.
No Cardiovascular Events
|
47 participants
|
48 participants
|
46 participants
|
|
Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.
No Deaths
|
47 participants
|
48 participants
|
46 participants
|
PRIMARY outcome
Timeframe: Within 48 hours after carotid artery stenting.Population: The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.
Outcome measures
| Measure |
RIPC Group
n=52 Participants
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
n=56 Participants
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
n=54 Participants
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.
With new lesions on post-treatment scans
|
10 participants
|
26 participants
|
23 participants
|
|
Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.
Without new lesions on post-treatment scans
|
42 participants
|
30 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Baseline, on admission, and 1 and 24 hours after carotid artery stenting.Population: The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.
Outcome measures
| Measure |
RIPC Group
n=52 Participants
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
n=56 Participants
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
n=54 Participants
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Serum High-sensitive C-reactive Protein (Hs-CRP).
24 hours after CAS
|
5.09 mg/L
Interval 2.29 to 11.54
|
7.90 mg/L
Interval 4.63 to 13.9
|
6.90 mg/L
Interval 3.75 to 9.72
|
|
Serum High-sensitive C-reactive Protein (Hs-CRP).
Baseline
|
1.23 mg/L
Interval 0.69 to 4.73
|
1.22 mg/L
Interval 0.76 to 4.67
|
1.37 mg/L
Interval 0.81 to 3.77
|
|
Serum High-sensitive C-reactive Protein (Hs-CRP).
On admission
|
0.99 mg/L
Interval 0.59 to 3.51
|
1.09 mg/L
Interval 0.85 to 2.56
|
1.35 mg/L
Interval 0.57 to 3.69
|
|
Serum High-sensitive C-reactive Protein (Hs-CRP).
1 hour after CAS
|
1.31 mg/L
Interval 0.61 to 2.93
|
1.46 mg/L
Interval 0.78 to 3.6
|
1.55 mg/L
Interval 1.09 to 4.18
|
SECONDARY outcome
Timeframe: From baseline to 6 months after treatment.The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS.
Outcome measures
| Measure |
RIPC Group
n=48 Participants
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
n=50 Participants
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
n=49 Participants
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, on admission, and 1 and 24 hours after carotid artery stenting.Population: The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.
Outcome measures
| Measure |
RIPC Group
n=52 Participants
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
n=56 Participants
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
n=54 Participants
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Serum Neuron Specific Enolase (NSE) Levels.
Baseline
|
12.83 ng/L
Standard Deviation 3.07
|
12.51 ng/L
Standard Deviation 2.92
|
12.12 ng/L
Standard Deviation 2.76
|
|
Serum Neuron Specific Enolase (NSE) Levels.
On admission
|
12.63 ng/L
Standard Deviation 3.77
|
12.85 ng/L
Standard Deviation 3.59
|
12.56 ng/L
Standard Deviation 2.71
|
|
Serum Neuron Specific Enolase (NSE) Levels.
1 hour after CAS
|
13.00 ng/L
Standard Deviation 2.85
|
13.18 ng/L
Standard Deviation 3.98
|
13.01 ng/L
Standard Deviation 4.32
|
|
Serum Neuron Specific Enolase (NSE) Levels.
24 hours after CAS
|
12.65 ng/L
Standard Deviation 2.78
|
12.97 ng/L
Standard Deviation 4.28
|
12.77 ng/L
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Baseline, on admission, and 1 and 24 hours after carotid artery stenting.Population: The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.
Outcome measures
| Measure |
RIPC Group
n=52 Participants
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
n=56 Participants
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
n=54 Participants
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Serum S-100B Levels.
Baseline
|
49.64 pg/mL
Standard Deviation 15.74
|
50.14 pg/mL
Standard Deviation 17.04
|
50.42 pg/mL
Standard Deviation 13.62
|
|
Serum S-100B Levels.
On admission
|
49.70 pg/mL
Standard Deviation 16.25
|
50.75 pg/mL
Standard Deviation 16.79
|
51.24 pg/mL
Standard Deviation 13.30
|
|
Serum S-100B Levels.
1 hour after CAS
|
50.99 pg/mL
Standard Deviation 20.21
|
51.19 pg/mL
Standard Deviation 22.40
|
51.79 pg/mL
Standard Deviation 19.42
|
|
Serum S-100B Levels.
24 hours after CAS
|
51.40 pg/mL
Standard Deviation 16.16
|
52.94 pg/mL
Standard Deviation 24.34
|
52.02 pg/mL
Standard Deviation 19.71
|
Adverse Events
RIPC Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Control Group
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Sham RIPC Group
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RIPC Group
n=52 participants at risk
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
n=56 participants at risk
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
n=54 participants at risk
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Nervous system disorders
Hyperperfusion Syndrome
|
0.00%
0/52 • Through 6 months post carotid artery stenting.
|
1.8%
1/56 • Number of events 1 • Through 6 months post carotid artery stenting.
|
0.00%
0/54 • Through 6 months post carotid artery stenting.
|
|
Nervous system disorders
Symptomatic Ischemic Stroke
|
0.00%
0/52 • Through 6 months post carotid artery stenting.
|
3.6%
2/56 • Number of events 2 • Through 6 months post carotid artery stenting.
|
3.7%
2/54 • Number of events 2 • Through 6 months post carotid artery stenting.
|
|
Nervous system disorders
Transient Ischemic Attack
|
1.9%
1/52 • Number of events 1 • Through 6 months post carotid artery stenting.
|
0.00%
0/56 • Through 6 months post carotid artery stenting.
|
1.9%
1/54 • Number of events 1 • Through 6 months post carotid artery stenting.
|
Other adverse events
| Measure |
RIPC Group
n=52 participants at risk
Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.
Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Control Group
n=56 participants at risk
Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
Sham RIPC Group
n=54 participants at risk
Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.
Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
|
|---|---|---|---|
|
Nervous system disorders
At least one new lesion
|
19.2%
10/52 • Number of events 10 • Through 6 months post carotid artery stenting.
|
46.4%
26/56 • Number of events 26 • Through 6 months post carotid artery stenting.
|
42.6%
23/54 • Number of events 23 • Through 6 months post carotid artery stenting.
|
Additional Information
Xunming Ji, M.D.,Ph.D
XuanWu Hospital, Capital Medical University
Phone: 8683198127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place