Trial Outcomes & Findings for Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3 (NCT NCT02586415)
NCT ID: NCT02586415
Last Updated: 2019-05-21
Results Overview
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
182 participants
Primary outcome timeframe
Day 90
Results posted on
2019-05-21
Participant Flow
From May 2016 through May 2017, a total of 182 patients underwent randomization (92 to the endovascular-therapy group and 90 to the medical-therapy group) at 38 centers in the United States.
After obtaining written informed consent, participants were randomized if they met all clinical and imaging eligibility requirements and could undergo initiation of endovascular therapy between 6 and 16 hours after the time that they had last been known to be well.
Participant milestones
| Measure |
Endovascular Thrombectomy Therapy
Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.
Devices approved for use in DEFUSE 3:
* Trevo Retriever
* Solitaire™ FR Revascularization Device
* Penumbra thrombectomy system
* Covidien MindFrame Capture Revascularization Device
Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.
Trevo Retriever: Trevo R
|
Medical Management
standard medical therapy alone
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
90
|
|
Overall Study
24 Hour Assessment
|
91
|
90
|
|
Overall Study
Day 30 Assessment
|
81
|
70
|
|
Overall Study
Day 90 Assessment
|
78
|
65
|
|
Overall Study
COMPLETED
|
78
|
65
|
|
Overall Study
NOT COMPLETED
|
14
|
25
|
Reasons for withdrawal
| Measure |
Endovascular Thrombectomy Therapy
Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.
Devices approved for use in DEFUSE 3:
* Trevo Retriever
* Solitaire™ FR Revascularization Device
* Penumbra thrombectomy system
* Covidien MindFrame Capture Revascularization Device
Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.
Trevo Retriever: Trevo R
|
Medical Management
standard medical therapy alone
|
|---|---|---|
|
Overall Study
Death
|
13
|
23
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3
Baseline characteristics by cohort
| Measure |
Endovascular Thrombectomy Therapy
n=92 Participants
Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.
Devices approved for use in DEFUSE 3:
* Trevo Retriever
* Solitaire™ FR Revascularization Device
* Penumbra thrombectomy system
* Covidien MindFrame Capture Revascularization Device
Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.
|
Medical Management
n=90 Participants
standard medical therapy alone
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
71 years
n=7 Participants
|
70.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
NIHSS, continuous
|
16 units on a scale
n=5 Participants
|
16 units on a scale
n=7 Participants
|
16 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: intention to treat
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Outcome measures
| Measure |
Endovascular Thrombectomy Therapy
n=92 Participants
Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.
Devices approved for use in DEFUSE 3:
* Trevo Retriever
* Solitaire™ FR Revascularization Device
* Penumbra thrombectomy system
* Covidien MindFrame Capture Revascularization Device
Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.
|
Medical Management
n=90 Participants
standard medical therapy alone
|
|---|---|---|
|
The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90
|
3 score on a scale
Interval 1.0 to 4.0
|
4 score on a scale
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: day 90Population: intention to treat
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms. * No significant disability. Able to carry out all usual activities, despite some symptoms. * Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. * Moderate disability. Requires some help, but able to walk unassisted. * Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. * Severe disability. Requires constant nursing care and attention, bedridden, incontinent. * Dead.
Outcome measures
| Measure |
Endovascular Thrombectomy Therapy
n=92 Participants
Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.
Devices approved for use in DEFUSE 3:
* Trevo Retriever
* Solitaire™ FR Revascularization Device
* Penumbra thrombectomy system
* Covidien MindFrame Capture Revascularization Device
Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.
|
Medical Management
n=90 Participants
standard medical therapy alone
|
|---|---|---|
|
Count of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence
|
41 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 hoursDefined as NIHSS worsening of 4 or more points associated with brain hemorrhage within 36 hours of randomization
Outcome measures
| Measure |
Endovascular Thrombectomy Therapy
n=92 Participants
Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.
Devices approved for use in DEFUSE 3:
* Trevo Retriever
* Solitaire™ FR Revascularization Device
* Penumbra thrombectomy system
* Covidien MindFrame Capture Revascularization Device
Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.
|
Medical Management
n=90 Participants
standard medical therapy alone
|
|---|---|---|
|
Count of Participants With Symptomatic Intracranial Hemorrhage (Primary Safety Outcome)
|
6 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 (±6) hoursPH 2 rates on the 24 hour scan (±6)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 (+/- 6) hoursInfarct volume on diffusion-weighted MRI (or CT if MRI not feasible) at 24 (±6) hours after randomization
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours (±6)Lesion growth between the RAPID-identified ischemic core on baseline imaging and the infarct volume at 24 hours (±6)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: between baseline and 24 hours (+/- 6 hours)Successful reperfusion defined as a \>90% reduction in Tmax\>6sec lesion volume between baseline and 24 hours
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours (±6)Recanalization of the primary arterial occlusive lesion at 24-hours on CTA/MRA
Outcome measures
Outcome data not reported
Adverse Events
Endovascular Thrombectomy Therapy
Serious events: 40 serious events
Other events: 57 other events
Deaths: 13 deaths
Medical Management
Serious events: 48 serious events
Other events: 59 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Endovascular Thrombectomy Therapy
n=92 participants at risk
Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.
Devices approved for use in DEFUSE 3:
* Trevo Retriever
* Solitaire™ FR Revascularization Device
* Penumbra thrombectomy system
* Covidien MindFrame Capture Revascularization Device
Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.
|
Medical Management
n=90 participants at risk
standard medical therapy alone
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/92 • Number of events 1 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Nervous system disorders
Aphasia
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
General disorders
Asthenia
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/92 • Number of events 1 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Brain oedema
|
4.3%
4/92 • Number of events 4 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/92 • Number of events 1 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.2%
2/92 • Number of events 2 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Cardiopulmonary failure
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Carotid artery dissection
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Cerebellar haemorrhage
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.1%
1/92 • Number of events 1 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Nervous system disorders
Cerebral infarction
|
2.2%
2/92 • Number of events 2 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Nervous system disorders
Cerebrovascular accident
|
2.2%
2/92 • Number of events 2 • 3 months
|
5.6%
5/90 • Number of events 5 • 3 months
|
|
General disorders
Chest pain
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Gastrointestinal disorders
Chronic gastrointestinal bleeding
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
General disorders
Death
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Psychiatric disorders
Depression
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Product Issues
Device occlusion
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Vascular disorders
Embolism
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.2%
2/92 • Number of events 2 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
3.3%
3/92 • Number of events 3 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Vascular disorders
Hypotension
|
2.2%
2/92 • Number of events 2 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Vascular disorders
Hypovolaemic shock
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Neurological decompensation
|
2.2%
2/92 • Number of events 2 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.3%
3/92 • Number of events 3 • 3 months
|
5.6%
5/90 • Number of events 5 • 3 months
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Infections and infestations
Pneumonia
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/92 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/92 • Number of events 1 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/92 • Number of events 1 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Seizure
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Infections and infestations
Sepsis
|
1.1%
1/92 • Number of events 1 • 3 months
|
4.4%
4/90 • Number of events 4 • 3 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Nervous system disorders
Somnolence
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Stroke in evolution
|
3.3%
3/92 • Number of events 3 • 3 months
|
10.0%
9/90 • Number of events 9 • 3 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Syncope
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Vascular disorders
Thrombosis
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Infections and infestations
Urosepsis
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Infections and infestations
Wound infection
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
Other adverse events
| Measure |
Endovascular Thrombectomy Therapy
n=92 participants at risk
Treatment with one or more thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy for patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile.
Devices approved for use in DEFUSE 3:
* Trevo Retriever
* Solitaire™ FR Revascularization Device
* Penumbra thrombectomy system
* Covidien MindFrame Capture Revascularization Device
Endovascular Thrombectomy: Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.
|
Medical Management
n=90 participants at risk
standard medical therapy alone
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
2/92 • Number of events 2 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/92 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
3/92 • Number of events 3 • 3 months
|
4.4%
4/90 • Number of events 4 • 3 months
|
|
Psychiatric disorders
Anxiety
|
2.2%
2/92 • Number of events 2 • 3 months
|
0.00%
0/90 • 3 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Atrial fibrillation
|
6.5%
6/92 • Number of events 6 • 3 months
|
5.6%
5/90 • Number of events 5 • 3 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/92 • Number of events 1 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Infections and infestations
Bacteraemia
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Infections and infestations
Bacterial disease carrier
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Investigations
Blood creatinine increased
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Investigations
Blood glucose increased
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Bradyarrhythmia
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Nervous system disorders
Brain oedema
|
1.1%
1/92 • Number of events 2 • 3 months
|
0.00%
0/90 • 3 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Infections and infestations
Cellulitis
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Nervous system disorders
Cerebellar haemorrhage
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Cerebellar infarction
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
4.3%
4/92 • Number of events 4 • 3 months
|
4.4%
4/90 • Number of events 4 • 3 months
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/92 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
General disorders
Chills
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
2/92 • Number of events 2 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Psychiatric disorders
Depression
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
1/92 • Number of events 1 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
3/92 • Number of events 3 • 3 months
|
4.4%
4/90 • Number of events 4 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Extrasystoles
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Infections and infestations
Fungal infection
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Vascular disorders
Haematoma
|
3.3%
3/92 • Number of events 3 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
5.4%
5/92 • Number of events 5 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
16.3%
15/92 • Number of events 16 • 3 months
|
11.1%
10/90 • Number of events 10 • 3 months
|
|
Nervous system disorders
Headache
|
5.4%
5/92 • Number of events 5 • 3 months
|
4.4%
4/90 • Number of events 4 • 3 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
1/92 • Number of events 1 • 3 months
|
4.4%
4/90 • Number of events 4 • 3 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Vascular disorders
Hypertension
|
4.3%
4/92 • Number of events 4 • 3 months
|
4.4%
4/90 • Number of events 4 • 3 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.3%
3/92 • Number of events 3 • 3 months
|
5.6%
5/90 • Number of events 5 • 3 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.1%
1/92 • Number of events 1 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Vascular disorders
Hypotension
|
5.4%
5/92 • Number of events 5 • 3 months
|
5.6%
5/90 • Number of events 5 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Nervous system disorders
Intracranial aneurysm
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.1%
1/92 • Number of events 1 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/92 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
3.3%
3/92 • Number of events 3 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/92 • 3 months
|
5.6%
5/90 • Number of events 5 • 3 months
|
|
Nervous system disorders
Neuropathy peripheral
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
General disorders
Pain
|
0.00%
0/92 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
4.3%
4/92 • Number of events 4 • 3 months
|
5.6%
5/90 • Number of events 5 • 3 months
|
|
Infections and infestations
Pneumonia
|
1.1%
1/92 • Number of events 1 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.3%
3/92 • Number of events 3 • 3 months
|
0.00%
0/90 • 3 months
|
|
General disorders
Pyrexia
|
7.6%
7/92 • Number of events 7 • 3 months
|
4.4%
4/90 • Number of events 4 • 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
3/92 • Number of events 3 • 3 months
|
0.00%
0/90 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Restless legs syndrome
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Seizure
|
2.2%
2/92 • Number of events 2 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Cardiac disorders
Sinus bradycardia
|
2.2%
2/92 • Number of events 2 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Nervous system disorders
Spinal cord oedema
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Nervous system disorders
Stroke in evolution
|
1.1%
1/92 • Number of events 1 • 3 months
|
3.3%
3/90 • Number of events 3 • 3 months
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/92 • Number of events 1 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
General disorders
Tenderness
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Vascular disorders
Thrombosis
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Investigations
Transaminases increased
|
1.1%
1/92 • Number of events 1 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Investigations
Troponin increased
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Investigations
Troponin
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/92 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Renal and urinary disorders
Urinary retention
|
3.3%
3/92 • Number of events 3 • 3 months
|
2.2%
2/90 • Number of events 2 • 3 months
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Infections and infestations
Urinary tract infection
|
4.3%
4/92 • Number of events 4 • 3 months
|
11.1%
10/90 • Number of events 10 • 3 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Vascular disorders
Vasospasm
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Cardiac disorders
Ventricular tachycardia
|
2.2%
2/92 • Number of events 2 • 3 months
|
0.00%
0/90 • 3 months
|
|
Vascular disorders
Vessel perforation
|
1.1%
1/92 • Number of events 1 • 3 months
|
0.00%
0/90 • 3 months
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/92 • 3 months
|
1.1%
1/90 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
3/92 • Number of events 3 • 3 months
|
0.00%
0/90 • 3 months
|
Additional Information
Dr. Gregory Albers
Stanford University/School of Medicine
Phone: 650-723-4448
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place