Post-Market Registry Of Stroke Patients Treated With Medtronic Neuro Thrombectomy Devices to Collect Real World Data in South East Asia

NCT03364023 | Completed Results FDA Device

• 1 other identifier: MDT16066SOLSEA
• Study Type: observational
• Target: 183
• Locations: 3 countries
• Sites: 10

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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS) at 90 Days

  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

  90 Days Post Procedure

Secondary Outcomes (3)

• Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure

  24 hrs ± 8 hrs post procedure

• All-Cause Mortality Through 90 Days Post Procedure

  90 Days Post Procedure

• Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure

  24 hrs ± 8 hrs post procedure

Study Arms (1)

Acute Ischemic Stroke Patients

Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device

Device: Neurothrombectomy

Interventions

Neurothrombectomy DEVICE

Medtronic Market-Released Neurothrombectomy Device

Acute Ischemic Stroke Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AIS patients treated with a Medtronic market-released neurothrombectomy device.

You may qualify if:

• Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements.
• 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.
• Subject has been or will be treated with a Medtronic market-released neurothrombectomy device as the initial device used to remove the thrombus.
• Subject is willing to participate in a 90-day follow-up visit.
• Treatment within 8 hours of stroke symptom onset (defined as stroke onset to access puncture).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (10)

National Neuroscience Institute

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

Prasat Neurology Institute

Bangkok, Thailand

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

108 Military Central Hospital

Hanoi, Vietnam

Location

Bach Mai Hospital

Hanoi, Vietnam

Location

Ho Chi Minh City Medicine and Pharmacy University

Ho Chi Minh City, Vietnam

Location

The People's 115 Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Medtronic Neurovascular Clinical Affairs
• Organization: Medtronic Neurovascular Clinical Affairs

rs.nvclinicalprospr-sea@medtronic.com

9498373700

Study Officials

• Ka Sing Lawrence Wong, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 6, 2017
• Study Start: January 1, 2018
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3); TH (3); VN (4)