NCT07599904

Brief Summary

Post-Market Registry

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
62mo left

Started May 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jul 2031

First Submitted

Initial submission to the registry

April 14, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

5.2 years

First QC Date

April 14, 2026

Last Update Submit

May 14, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Evaluate device safety

    Incidence of Safety Events of Interest through 90-day follow-up

    From Day 0 to 90 days post-procedure

  • Evaluate device performance

    Reperfusion defined as eTICI ≥2b50; ≥2b67; ≥2c; =3 at end of procedure.

    Day 0 - end of index stroke procedure

  • Evaluate device effectiveness

    Functional independence as measured by modified Rankin Scale (mRS) score ≤ 2 at 90-day follow up (mRS scores range from 0 \[no symptoms\] to 6 \[death\]).

    From Day 0 to 90 days post-procedure

Interventions

Index stroke procedure and follow-up visits up to 90 days post index procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring treatment with Medtronic Neurovascular commercially available devices used during the treatment of acute ischemic stroke (AIS)

You may qualify if:

  • Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
  • Participant is treated or intended to be treated with a commercially available Medtronic Neurovascular device\* during treatment for acute ischemic stroke.
  • Participant is 18 years of age or older.

You may not qualify if:

  • Participant who may be unable to complete follow-up within the registry.
  • Participant of child-bearing potential who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
  • Participant is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results based on Principal Investigator's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

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

April 14, 2026

First Posted

May 20, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Last Updated

May 20, 2026

Record last verified: 2026-05