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

Stroke, Acute Clinical Trial

— PROSPR-SEA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364023
• Other study ID #: MDT16066SOLSEA
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: July 2, 2019

Study information

• Verified date: July 2020
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 2, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• Neurothrombectomy
Medtronic Market-Released Neurothrombectomy Device

Locations

Country	Name	City	State
Singapore	National Neuroscience Institute	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Thailand	Prasat Neurology Institute	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Vietnam	108 Military Central Hospital	Hanoi
Vietnam	Bach Mai Hospital	Hanoi
Vietnam	Ho Chi Minh City Medicine and Pharmacy University	Ho Chi Minh City
Vietnam	The People's 115 Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Countries where clinical trial is conducted

Singapore,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	90 Days Post Procedure
Secondary	Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 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.	24 hrs ± 8 hrs post procedure
Secondary	All-Cause Mortality Through 90 Days Post Procedure	Death through 90 days post procedure classified as neurological or non-neurological, with event leading to death.	90 Days Post Procedure
Secondary	Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure	Emboli in New Territory (ENT) is defined as embolization territories outside of the target downstream territory.	24 hrs ± 8 hrs post procedure