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

NCT07760649 | Not Yet Recruiting

• 1 other identifier: CNV202508
• Study Type: observational
• Target: 5,000
• Locations: 2 countries
• Sites: 3

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).

Conditions

Ischemic Stroke

Outcome Measures

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.

  Up to 90 days post-procedure

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuravi Limited: lead

Study Sites (3)

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20251, Germany

Location

Stadtisches Klinikum Solingen gemeinnutzige GmbH

Solingen, 42653, Germany

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Neuravi Limited Clinical Trial

  Neuravi Limited

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): October 16, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CH (1); DE (2)