A Study to Monitor Safety and Effectiveness of Approved J&J MedTech Devices in the Treatment of Participants With Ischemic Stroke

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNeuravi Limited

About this trial

The purpose of this study is to collect medical information to monitor the ongoing safety of the J\&J MedTech devices and to understand how well they work when routinely used to treat participants with acute ischemic stroke (a condition caused by a blocked blood vessel in the brain).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is 18 years of age or older at the time of consent

Informed Consent has been provided by the participant or the participants' legally authorized representative (LAR)

Participants with angiographic confirmation of acute ischemic stroke

A clinical decision has been made to treat the participant with an eligible Johnson & Johnson MedTech neuro-thrombectomy device independently and prior to enrollment in the study

Disqualifiers

Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding

Current involvement in an investigational (drug, device, etcetera) clinical study that may confound study endpoints. Sponsor approval is required prior to enrollment

Trial population

The study population will include participants with angiographic confirmation of acute ischemic stroke who are scheduled to undergo/have undergone mechanical thrombectomy using one or more of the study devices as specified in the protocol.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 1 trial group
Group A: Participants With Acute Ischemic Stroke

Trial outcomes

Primary outcomes

1

Revascularization (Modified Thrombolysis in Cerebrovascular Infarction [mTICI])

Revascularization is defined as achieving a specific minimum mTICI score, such as 2b or greater. mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke with grades as follows: mTICI 0 = no perfusion; mTICI 1 = penetration but not perfusion; mTICI 2a = some perfusion with distal branch filling of less than (\<)50 percent (%) of territory visualized; mTICI 2b = substantial perfusion with distal branch filling of \>=50% of territory visualized; mTICI 2c = near-complete perfusion; mTICI 3 = complete perfusion.

Time frame
Up to 90 days post-procedure

Secondary outcomes

1

Percentage of Participants With Modified Rankin Scale (mRS) Score of <=2 or no Worsening at 90 Days

Percentage of participants with mRS score of \<=2, or no worsening from baseline, at 90 days will be reported. The mRS is a commonly used 7-point disability scale with possible scores ranging from 0 (no symptoms) to 6 (Death).

Time frame
At 90 days post-procedure
2

90-Day All-Cause Mortality

All mortality regardless of causes through 90 days post procedure will be reported.

Time frame
At 90 Days Post-Procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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