Postmarket Study of Tarvos Microguidewire in Neurovascula... | NCT07500155

Studies
Postmarket Study of Tarvos Microguidewire in Neurovascular Interventional Surgery

NCT07500155

Sponsor

Keuro MedTech

Status

Completed

Last Update Posted

Apr 2, 2026Actual

Enrollment

121Actual

Phase

Not provided

Conditions

Intracranial Aneurysm
AVM - Cerebral Arteriovenous Malformation
AV Fistula
Acute Ischemic Stroke
Extracranial Atherosclerosis

Interventions

Tarvos Microguidewire

Countries

China

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

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2026Actual

Primary Completion Date

Mar 15, 2026Actual

Completion Date

Mar 15, 2026Actual

First Submitted Date

Mar 24, 2026

First Submission Date that Met QC Criteria

Mar 24, 2026

First Posted Date

Mar 30, 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

Mar 29, 2026

Last Update Posted Date

Apr 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This investigation is to evaluate the clinical effectiveness and safety of the Tarvos Microguidewire in the neurovascular interventional surgery. It is a retrospective multicenter medical device clinical study with real-world data.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single arm			Device: Tarvos Microguidewire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tarvos Microguidewire	Device	This product is indicated for use in neurovascular interventions to assist in the delivery of diagnostic or therapeutic devices to the target lesion site.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Device success rate	Number of patients with device success / Number of recruited patients* 100%	during surgery

Secondary Outcomes

Measure	Description	Time Frame
Ability to assist in the delivery of other interventional devices to the targeted vessel position.		during surgery

Other Outcomes

Measure	Description	Time Frame
Incidence of adverse events, serious adverse events and device deficiencies		within postoperative 24 hrs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undertaken a neurovascular surgery procedure including Tarvos microguidewire
Available images of Tarvos Microguidewire in the neurovascular surgery.

Exclusion Criteria:

Disorders of vascular fragility (e.g. Ehlers-Danlos syndrome)
Prior vascular dissection or injury to the target vessels
Not meeting the data requirements needed for this study.

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

Undertaken a neurovascular surgery procedure including Tarvos Microguidewire

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xingtai central hospital		Xingtai			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002532	Intracranial Aneurysm
D002538	Intracranial Arteriovenous Malformations
D001164	Arteriovenous Fistula
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided