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Recruiting

NCT Number: NCT07599904

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

Post-Market Registry

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McLaren Flint Hospital, Flint, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mechanical Thrombectomy

Device

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

Primary outcomes

  1. Evaluate device safety

    Time frame: From Day 0 to 90 days post-procedure

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

  2. Evaluate device performance

    Time frame: Day 0 - end of index stroke procedure

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

  3. 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]).

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Salisbury

CONTACT

[email protected]

612-979-7251

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Acronym: RECANOVA

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
May 20, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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