A Post-market Observational Study to Monitor Safety and Effectiveness in the Treatment of Patients With Ischemic Stroke Using Commercially Approved J&J MedTech Devices Optimized for Neurovascular Thrombectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 5,000
- Locations
- 3
- Primary Endpoint
- Revascularization (Modified Thrombolysis in Cerebrovascular Infarction [mTICI])
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Participants With Acute Ischemic Stroke
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 will be enrolled. Participants will have the procedure according to the standard of care (SOC) process of the hospital and physician preference. No treatment will be provided by the sponsor as a part of this study.
Outcomes
Primary Outcomes
Revascularization (Modified Thrombolysis in Cerebrovascular Infarction [mTICI])
Time Frame: Up to 90 days post-procedure
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(At 90 days post-procedure)
- 90-Day All-Cause Mortality(At 90 Days Post-Procedure)