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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
90-Day All-Cause Mortality
All mortality regardless of causes through 90 days post procedure will be reported.
Locations
Sponsors and contacts
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