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

N/ANot Yet RecruitingNCT07760649

Neuravi Limited5,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Ischemic Stroke

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Stadtisches Klinikum Solingen gemeinnutzige GmbH

Solingen, Germany

University Hospital Zurich

Zurich, Switzerland

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.

Time frame: Up to 90 days post-procedure

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).

Time frame: At 90 days post-procedure

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

Central Contacts

Study Contact

CONTACT

+ 41 (0) 792923126 MEugeni1@its.jnj.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.