REal-world Clinical evAulation of Medtronic NeurOVascular... | NCT07599904

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

NCT07599904

Sponsor

Medtronic Neurovascular Clinical Affairs

Status

Recruiting

Last Update Posted

Jun 18, 2026Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Acute Ischemic Stroke

Interventions

Device: Mechanical Thrombectomy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Jul 2031Estimated

Completion Date

Jul 2031Estimated

First Submitted Date

Apr 14, 2026

First Submission Date that Met QC Criteria

May 14, 2026

First Posted Date

May 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Post-Market Registry

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

90 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Device: Mechanical Thrombectomy	Procedure	Index stroke procedure and follow-up visits up to 90 days post index procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephanie Salisbury	Contact	612-979-7251		rs.recanovaregistry@medtronic.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Buffalo General Medical Center	Recruiting	Buffalo	New York	14203	United States

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided