Trial Outcomes & Findings for Safety and Efficacy of SINOMED SR for Endovascular Treatment of Acute Ischemic Stroke (NCT NCT04973332)
NCT ID: NCT04973332
Last Updated: 2026-02-27
Results Overview
The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
218 participants
Primary outcome timeframe
Within 24 hours post-procedure
Results posted on
2026-02-27
Participant Flow
Participant milestones
| Measure |
Thrombectomy-SINOMED SR
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
109
|
|
Overall Study
COMPLETED
|
109
|
109
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Thrombectomy-SINOMED SR
n=109 Participants
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=109 Participants
Intracranial thrombectomy was performed with a control product（name:Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.76 years
STANDARD_DEVIATION 10.43 • n=109 Participants
|
63.97 years
STANDARD_DEVIATION 9.52 • n=109 Participants
|
63.36 years
STANDARD_DEVIATION 9.98 • n=218 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=109 Participants
|
50 Participants
n=109 Participants
|
91 Participants
n=218 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=109 Participants
|
59 Participants
n=109 Participants
|
127 Participants
n=218 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
109 participants
n=109 Participants
|
109 participants
n=109 Participants
|
218 participants
n=218 Participants
|
|
Pre-onset mRS < 2
|
107 Participants
n=109 Participants
|
109 Participants
n=109 Participants
|
216 Participants
n=218 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours post-procedureThe criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=109 Participants
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=109 Participants
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Number of Participants With Successful Immediate Recanalization
|
105 participants
|
103 participants
|
SECONDARY outcome
Timeframe: pre-procedure, and 90 days post-procedureThe Modified Rankin Scale is a global measure of functional disability ranging from 0 (no symptoms) to 6 (death), where lower scores indicate a better outcome. A score of 0-2 is commonly interpreted as a favorable functional outcome.
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=109 Participants
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=109 Participants
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Number of Participants With a Modified Rankin Scale (mRS) Score of 0-2 Points at 90 Days After Surgery
|
48 participants
|
43 participants
|
SECONDARY outcome
Timeframe: intra-operativeThe time from femoral artery puncture to vascular recanalization or the end time of surgery for patients with no vascular recanalization. Vascular recanalization time = successful recanalization time - femoral artery puncture time
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=109 Participants
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=109 Participants
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Vascular Recanalization Time
|
95.55 Min
Standard Deviation 64.70
|
79.58 Min
Standard Deviation 46.38
|
SECONDARY outcome
Timeframe: 7 days post-procedureThe number of subjects exhibiting a \>4-point decrease on the National Institutes of Health Stroke Scale (NIHSS; range 0-42, where higher scores indicate worse neurological deficit).
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=100 Participants
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=99 Participants
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
The National Institute of Health Stroke Scale Score Decreased the Rate of Subjects With > 4 Points
|
66 participants
|
50 participants
|
SECONDARY outcome
Timeframe: intra-operativeDevices Successfully Operated defined devices completed conveying, releasing and retracting.
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=112 Overall Number of Devices Analyzed
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=112 Overall Number of Devices Analyzed
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Number of Devices Successfully Operated
|
112 device
|
112 device
|
SECONDARY outcome
Timeframe: within 24 hours post-procedureSymptomatic intracranial hemorrhage within 24 h, specifically intracranial hemorrhage (intracranial parenchymal hematoma, subarachnoid hemorrhage, and ventricular hemorrhage) accompanied by neurological deterioration
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=104 Participants
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=103 Participants
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Number of Participants Who Experienced Symptomatic Intracranial Hemorrhage Within 24 h Post-procedure
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: within 90 daysThe count of all deaths from any cause occurring within 90 days post-procedure among participants who received the intracranial thrombectomy stent.
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=109 Participants
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=109 Participants
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Number of Participants Who Died Within 90 Days
|
23 participants
|
33 participants
|
SECONDARY outcome
Timeframe: intra-operativeThe count of defects (e.g., device breakage, incorrect labeling) identified in the research devices during the clinical trial.
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=112 Overall Number of Devices Analyzed
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=112 Overall Number of Devices Analyzed
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Number of Device Defects
|
0 device
|
0 device
|
SECONDARY outcome
Timeframe: Within 90 days post-procedureThe count of participants who experienced at least one serious adverse event (SAE) after receiving thrombectomy with the intracranial thrombectomy device.
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=109 Participants
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=109 Participants
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE)
|
33 participants
|
46 participants
|
SECONDARY outcome
Timeframe: Within 90 days post-procedureThe count of participants who experienced at least one adverse event (AE) after receiving thrombectomy with the intracranial thrombectomy device.
Outcome measures
| Measure |
Thrombectomy-SINOMED SR
n=109 Participants
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=109 Participants
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Number of Participants With Adverse Events (AE)
|
104 participants
|
103 participants
|
Adverse Events
Thrombectomy-SINOMED SR
Serious events: 33 serious events
Other events: 103 other events
Deaths: 23 deaths
Thrombectomy-Solitaire FR
Serious events: 46 serious events
Other events: 94 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Thrombectomy-SINOMED SR
n=109 participants at risk
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=109 participants at risk
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Cardiac disorders
Rapid atrial fibrillation
|
0.92%
1/109 • within 90d postoperatively
|
0.00%
0/109 • within 90d postoperatively
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.92%
1/109 • within 90d postoperatively
|
0.00%
0/109 • within 90d postoperatively
|
|
Cardiac disorders
Recurrent cardioembolism
|
0.92%
1/109 • within 90d postoperatively
|
0.00%
0/109 • within 90d postoperatively
|
|
Vascular disorders
Formation of intramural hematoma at the origin of the left common carotid artery
|
0.92%
1/109 • within 90d postoperatively
|
0.00%
0/109 • within 90d postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infection
|
0.92%
1/109 • within 90d postoperatively
|
2.8%
3/109 • within 90d postoperatively
|
|
Cardiac disorders
Coronary heart disease
|
0.00%
0/109 • within 90d postoperatively
|
1.8%
2/109 • within 90d postoperatively
|
|
Cardiac disorders
Heart failure
|
0.00%
0/109 • within 90d postoperatively
|
2.8%
3/109 • within 90d postoperatively
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.8%
2/109 • within 90d postoperatively
|
0.92%
1/109 • within 90d postoperatively
|
|
Cardiac disorders
Patent foramen ovale
|
0.00%
0/109 • within 90d postoperatively
|
0.92%
1/109 • within 90d postoperatively
|
|
Injury, poisoning and procedural complications
Brain herniation
|
5.5%
6/109 • within 90d postoperatively
|
3.7%
4/109 • within 90d postoperatively
|
|
Injury, poisoning and procedural complications
Cerebral edema
|
1.8%
2/109 • within 90d postoperatively
|
4.6%
5/109 • within 90d postoperatively
|
|
General disorders
Death
|
14.7%
16/109 • within 90d postoperatively
|
15.6%
17/109 • within 90d postoperatively
|
|
Surgical and medical procedures
Inferior vena cava filter placement
|
0.00%
0/109 • within 90d postoperatively
|
0.92%
1/109 • within 90d postoperatively
|
|
Nervous system disorders
cerebral infarction
|
0.92%
1/109 • within 90d postoperatively
|
8.3%
9/109 • within 90d postoperatively
|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.92%
1/109 • within 90d postoperatively
|
0.00%
0/109 • within 90d postoperatively
|
Other adverse events
| Measure |
Thrombectomy-SINOMED SR
n=109 participants at risk
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
Thrombectomy-Solitaire FR
n=109 participants at risk
Intracranial thrombectomy was performed with a control product（name: Solitaire FR）
Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
6.4%
7/109 • within 90d postoperatively
|
1.8%
2/109 • within 90d postoperatively
|
|
Gastrointestinal disorders
Stress ulcer
|
5.5%
6/109 • within 90d postoperatively
|
2.8%
3/109 • within 90d postoperatively
|
|
Cardiac disorders
Heart failure
|
2.8%
3/109 • within 90d postoperatively
|
6.4%
7/109 • within 90d postoperatively
|
|
Gastrointestinal disorders
Constipation
|
25.7%
28/109 • within 90d postoperatively
|
23.9%
26/109 • within 90d postoperatively
|
|
Nervous system disorders
Cerebral infarction
|
10.1%
11/109 • within 90d postoperatively
|
5.5%
6/109 • within 90d postoperatively
|
|
Metabolism and nutrition disorders
Hypoproteinemia
|
15.6%
17/109 • within 90d postoperatively
|
17.4%
19/109 • within 90d postoperatively
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.4%
19/109 • within 90d postoperatively
|
18.3%
20/109 • within 90d postoperatively
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.5%
6/109 • within 90d postoperatively
|
4.6%
5/109 • within 90d postoperatively
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
8.3%
9/109 • within 90d postoperatively
|
8.3%
9/109 • within 90d postoperatively
|
|
General disorders
Fever
|
5.5%
6/109 • within 90d postoperatively
|
2.8%
3/109 • within 90d postoperatively
|
|
Cardiac disorders
Atrial fibrillation
|
5.5%
6/109 • within 90d postoperatively
|
4.6%
5/109 • within 90d postoperatively
|
|
Gastrointestinal disorders
Diarrhea
|
11.0%
12/109 • within 90d postoperatively
|
13.8%
15/109 • within 90d postoperatively
|
|
Hepatobiliary disorders
Hepatic failure
|
3.7%
4/109 • within 90d postoperatively
|
5.5%
6/109 • within 90d postoperatively
|
|
Infections and infestations
Infection
|
25.7%
28/109 • within 90d postoperatively
|
18.3%
20/109 • within 90d postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
31.2%
34/109 • within 90d postoperatively
|
35.8%
39/109 • within 90d postoperatively
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.92%
1/109 • within 90d postoperatively
|
6.4%
7/109 • within 90d postoperatively
|
|
Metabolism and nutrition disorders
Hyperlactatemia
|
3.7%
4/109 • within 90d postoperatively
|
10.1%
11/109 • within 90d postoperatively
|
|
Nervous system disorders
Intracranial hemorrhage
|
12.8%
14/109 • within 90d postoperatively
|
21.1%
23/109 • within 90d postoperatively
|
|
Nervous system disorders
Cerebral edema
|
10.1%
11/109 • within 90d postoperatively
|
11.9%
13/109 • within 90d postoperatively
|
|
Infections and infestations
Urinary tract infection
|
6.4%
7/109 • within 90d postoperatively
|
5.5%
6/109 • within 90d postoperatively
|
|
Blood and lymphatic system disorders
Anemia
|
16.5%
18/109 • within 90d postoperatively
|
16.5%
18/109 • within 90d postoperatively
|
|
Renal and urinary disorders
Renal failure
|
5.5%
6/109 • within 90d postoperatively
|
6.4%
7/109 • within 90d postoperatively
|
|
Vascular disorders
Deep vein thrombosis (DVT) of the extremities
|
11.9%
13/109 • within 90d postoperatively
|
5.5%
6/109 • within 90d postoperatively
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
6.4%
7/109 • within 90d postoperatively
|
5.5%
6/109 • within 90d postoperatively
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place