Trial Outcomes & Findings for Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry (NCT NCT02239640)

Last Updated: 2019-06-07

Results Overview

Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches. Classification: grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes)

Recruitment status

COMPLETED

Target enrollment

984 participants

Primary outcome timeframe

Day 0-At the completion of the thrombectomy procedure

Results posted on

2019-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Randomized Observation registry.
Overall Study STARTED	984
Overall Study COMPLETED	767
Overall Study NOT COMPLETED	217

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-Randomized Observation registry.
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	72
Overall Study Death	142

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=984 Participants Subjects enrolled
Age, Continuous	67.8 years STANDARD_DEVIATION 14.73 • n=984 Participants
Sex: Female, Male Female	451 Participants n=984 Participants
Sex: Female, Male Male	533 Participants n=984 Participants

PRIMARY outcome

Timeframe: Day 0-At the completion of the thrombectomy procedure

Population: 824 participants contributed to this analysis

Outcome measures

Outcome measures
Measure	Successful Revascularization n=824 Participants Successful reperfusion (mTICI 2b-3) per imaging core lab
Number of Participants Assessed for Revascularization With mTICI Grades 2b-3	724 Participants

SECONDARY outcome

Timeframe: up to 90 days post index procedure

Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)

Outcome measures

Outcome measures
Measure	Successful Revascularization n=984 Participants Successful reperfusion (mTICI 2b-3) per imaging core lab
Incidence of Neurological Events of Interest	91 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days post index procedure

Outcome measures

Outcome measures
Measure	Successful Revascularization n=984 Participants Successful reperfusion (mTICI 2b-3) per imaging core lab
All-cause Mortality	142 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days post index procedure

Population: 906 participants contributed to this analysis

Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke. Clasiffication: 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. (lower values represent less disability)

Outcome measures

Outcome measures
Measure	Successful Revascularization n=906 Participants Successful reperfusion (mTICI 2b-3) per imaging core lab
Number of Participants With Good Functional Outcome (mRS 0-2)	512 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days post index procedure

Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.

Outcome measures

Outcome measures
Measure	Successful Revascularization n=984 Participants Successful reperfusion (mTICI 2b-3) per imaging core lab
Incidence of Device Related Serious Adverse Events	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0-At the completion of the thrombectomy procedure

Population: 939 patients were analyzed

Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa.

Outcome measures

Outcome measures
Measure	Successful Revascularization n=939 Participants Successful reperfusion (mTICI 2b-3) per imaging core lab
Time to Revascularization	45.6 minutes Standard Deviation 29.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days post index procedure

Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.

Outcome measures

Outcome measures
Measure	Successful Revascularization n=984 Participants Successful reperfusion (mTICI 2b-3) per imaging core lab
Incidence of Procedure Related Serious Adverse Events	17 Participants

Adverse Events

Serious events: 19 serious events

Other events: 0 other events

Deaths: 142 deaths

Serious adverse events

Serious adverse events
Measure	Adverse Events n=984 participants at risk Serious adverse events reported per protocol during the study
Nervous system disorders Cartotid Artery Dissection	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Nervous system disorders Subarachnoid haemorrhage	0.51% 5/984 • Number of events 5 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Vascular disorders Arteriovenous fistula	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Nervous system disorders Carotid artery dissection	0.20% 2/984 • Number of events 2 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Nervous system disorders Cerebral haemorrhage	0.30% 3/984 • Number of events 3 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Vascular disorders Femoral artery dissection	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Nervous system disorders Headache	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Vascular disorders Hypotension	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Nervous system disorders Neurological decompensation	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Vascular disorders Peripheral artery thrombosis	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Vascular disorders Peripheral vascular disorder	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Nervous system disorders Stroke in evolution	0.30% 3/984 • Number of events 3 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Nervous system disorders Unresponsive to stimuli	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Vascular disorders Vasospasm	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.
Vascular disorders Vessel perforation	0.10% 1/984 • Number of events 1 • Up to 90 days post index stroke procedure Per protocol SAEs were collected up to 90 days post index stroke procedure: all-cause mortality, device-related SAE associated with the use of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure and procedure related SAE occurring upon insertion of Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure. Non-SAEs were not required to be collected per protocol.

Other adverse events

Adverse event data not reported

Additional Information

Oscar Bolanos

Medtronic

Phone: 949-527-0822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Researchers may Publish their individual site experience, but Sponsor reserves the exclusive right to Publish (or coordinate the Publication of) the complete accumulated results of the Registry, and to establish authorship criteria for such Publications for the Registry group based on Registry conduct and compliance, contribution to the Registry's design, management or enrollment and willingness to accept the rights and responsibilities of an author.
Publication restrictions are in place

Restriction type: OTHER