Clinical trial NCT03364023: Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia
Official title: Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia (PROSPR-SEA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 183
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AIS patients treated with a Medtronic market-released neurothrombectomy device.

Brief summary: The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia.

Detailed description: This is a prospective, multi-center, non-randomized, observational registry designed to collect real world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia, including Singapore, Thailand and Vietnam. The primary objective of this registry is to assess clinical outcomes associated with the use of these devices in patients experiencing AIS due to large intracranial vessel occlusion within 8 hours of symptom onset. This registry may enroll up to 500 patients.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility criteria: Inclusion Criteria:

1. Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements.
2. Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries.
3. Subject has been or will be treated with a Medtronic market-released neurothrombectomy device as the initial device used to remove the thrombus.
4. Subject is willing to participate in a 90-day follow-up visit.
5. Treatment within 8 hours of stroke symptom onset (defined as stroke onset to access puncture).

Exclusion Criteria:

1. Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis.

Primary outcomes:
measure: Modified Rankin Scale (mRS) at 90 Days
timeFrame: 90 Days Post Procedure
Secondary outcomes:
measure: Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure
timeFrame: 24 hrs ± 8 hrs post procedure
measure: All-Cause Mortality Through 90 Days Post Procedure
timeFrame: 90 Days Post Procedure
measure: Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure
timeFrame: 24 hrs ± 8 hrs post procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Neuroscience Institute
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Bangkok
country: Thailand
facility: Prasat Neurology Institute
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Hanoi
country: Vietnam
facility: 108 Military Central Hospital
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Ho Chi Minh City Medicine and Pharmacy University
city: Ho Chi Minh City
country: Vietnam
facility: The People's 115 Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Ka Sing Lawrence Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: