REal-world Clinical evAulation of Medtronic NeurOVascular Products for Acute Ischemic Stroke (RECANOVA Registry) (RECANOVA)

May 19, 2026 updated by: Medtronic Neurovascular Clinical Affairs
Post-Market Registry

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

An observational, prospective, multi-center, single-arm registry to provide continuing evaluation of safety and effectiveness of Medtronic Neurovascular commercially available products used in the treatment of acute ischemic stroke.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Buffalo General Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Participant who may be unable to complete follow-up within the registry.
  2. Participant of child-bearing potential who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate device safety
Time Frame: From Day 0 to 90 days post-procedure
Incidence of Safety Events of Interest through 90-day follow-up
From Day 0 to 90 days post-procedure
Evaluate device performance
Time Frame: Day 0 - end of index stroke procedure
Reperfusion defined as eTICI ≥2b50; ≥2b67; ≥2c; =3 at end of procedure.
Day 0 - end of index stroke procedure
Evaluate device effectiveness
Time Frame: From Day 0 to 90 days post-procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Neurovascular Clinical Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECANOVA Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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