- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07500155
Postmarket Study of Tarvos Microguidewire in Neurovascular Interventional Surgery
March 29, 2026 updated by: Keuro MedTech
Evaluation of Clinical Effectiveness and Safety of Tarvos Microguidewire in Neurovascular Interventional Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
121
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Xingtai, China
- Xingtai central hospital
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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
Undertaken a neurovascular surgery procedure including Tarvos Microguidewire
Description
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.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
single arm
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This product is indicated for use in neurovascular interventions to assist in the delivery of diagnostic or therapeutic devices to the target lesion site.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Device success rate
Time Frame: during surgery
|
Number of patients with device success / Number of recruited patients* 100%
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during surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ability to assist in the delivery of other interventional devices to the targeted vessel position.
Time Frame: during surgery
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during surgery
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of adverse events, serious adverse events and device deficiencies
Time Frame: within postoperative 24 hrs
|
within postoperative 24 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 29, 2026
Primary Completion (Actual)
March 15, 2026
Study Completion (Actual)
March 15, 2026
Study Registration Dates
First Submitted
March 24, 2026
First Submitted That Met QC Criteria
March 24, 2026
First Posted (Actual)
March 30, 2026
Study Record Updates
Last Update Posted (Actual)
April 2, 2026
Last Update Submitted That Met QC Criteria
March 29, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Nervous System Malformations
- Intracranial Arterial Diseases
- Aneurysm
- Stroke
- Vascular Malformations
- Fistula
- Arteriovenous Malformations
- Vascular Fistula
- Central Nervous System Vascular Malformations
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Ischemic Stroke
- Intracranial Aneurysm
- Arteriovenous Fistula
- Intracranial Arteriovenous Malformations
Other Study ID Numbers
- CIP-Reachx-RWD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
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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