Trial Outcomes & Findings for Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia (NCT NCT03364023)

Last Updated: 2020-08-19

Results Overview

mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead

Recruitment status

COMPLETED

Target enrollment

183 participants

Primary outcome timeframe

90 Days Post Procedure

Results posted on

2020-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Acute Ischemic Stroke Patients Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
Overall Study STARTED	183
Overall Study COMPLETED	166
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Acute Ischemic Stroke Patients Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
Overall Study Lost to Follow-up	3
Overall Study Death	14

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Ischemic Stroke Patients n=183 Participants Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
Age, Continuous	64.89 Years STANDARD_DEVIATION 13.67 • n=183 Participants
Sex: Female, Male Female	91 Participants n=183 Participants
Sex: Female, Male Male	92 Participants n=183 Participants
BMI	23.13 kg/m^2 STANDARD_DEVIATION 3.91 • n=183 Participants
Pre-stroke mRS mRS = 0	147 Participants n=183 Participants
Pre-stroke mRS mRS = 1	14 Participants n=183 Participants
Pre-stroke mRS mRS = 2	2 Participants n=183 Participants
Pre-stroke mRS mRS = 3	2 Participants n=183 Participants
Pre-stroke mRS mRS = 4	2 Participants n=183 Participants
Pre-stroke mRS mRS = 5	1 Participants n=183 Participants
Pre-stroke mRS Not Done	15 Participants n=183 Participants
Baseline NIHSS	15.20 units on a scale STANDARD_DEVIATION 5.88 • n=183 Participants

PRIMARY outcome

Timeframe: 90 Days Post Procedure

Outcome measures

Outcome measures
Measure	Acute Ischemic Stroke Patients n=180 Participants Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
Modified Rankin Scale (mRS) at 90 Days mRS = 0-2	112 Participants
Modified Rankin Scale (mRS) at 90 Days mRS = 3-6	68 Participants

SECONDARY outcome

Timeframe: 24 hrs ± 8 hrs post procedure

Number of participants with symptomatic Intracranial hemorrhage (sICH) is defined as \>/= 4 points worsening from baseline on the National Institutes of Health Stroke Scale (NIHSS) associated with an image finding of intra-cranial hemorrhage (i.e., intracerebral or intraventricular) at 24 +/- 8 hrs post procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.

Outcome measures

Outcome measures
Measure	Acute Ischemic Stroke Patients n=183 Participants Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure	14 Participants

SECONDARY outcome

Timeframe: 90 Days Post Procedure

Death through 90 days post procedure classified as neurological or non-neurological, with event leading to death.

Outcome measures

Outcome measures
Measure	Acute Ischemic Stroke Patients n=183 Participants Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
All-Cause Mortality Through 90 Days Post Procedure	14 Participants

SECONDARY outcome

Timeframe: 24 hrs ± 8 hrs post procedure

Emboli in New Territory (ENT) is defined as embolization territories outside of the target downstream territory.

Outcome measures

Outcome measures
Measure	Acute Ischemic Stroke Patients n=183 Participants Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure	6 Participants

Adverse Events

Acute Ischemic Stroke Patients

Serious events: 14 serious events

Other events: 0 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Acute Ischemic Stroke Patients n=183 participants at risk Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset.
Nervous system disorders Symptomatic Intracranial Hemorrhage (sICH)	7.7% 14/183 • Adverse Events were collected from the point of consent through 90 day follow up visit. For the purpose of this real-world registry, only the following Serious Adverse Events were collected: * Symptomatic Intracranial Hemorrhage (sICH) at 24 ± 8 hrs post procedure * Death through 90 days post procedure classified as neurological or non-neurological, with event leading to death Other \[Not including Serious\] Adverse Events were not monitored/assessed for this registry.

Other adverse events

Adverse event data not reported

Additional Information

Medtronic Neurovascular Clinical Affairs

Phone: 9498373700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place