Safety & Performance of the World Medica World Diverter Embolization Device

January 13, 2026 updated by: World Medica USA, LLC
The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio <2) or fusiform intracranial aneurysms in the internal carotid artery (ICA) from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.5 mm.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 22 to 80 years
  • Subject, or subject's legal representative provided informed consent
  • Subject agrees to the requirements of the study, including returning for required follow-up visits
  • Parent artery diameter of 2.0-5.5 mm distal and proximal to the target IA
  • Subject has a single target IA in the index procedure with the following characteristics: (1) Unruptured; (2) Located in the ICA from the petrous through the superior hypophyseal segments; and (3) Is a fusiform or saccular wide-necked IA with one of the following characteristics: (a) Small (< 5 mm) or medium (>5-10 mm) size with a neck width ≥ 4.0 mm or a dome-to-neck ratio of < 2; OR (b) Large (>10-25 mm) or giant (>25 mm) size

Exclusion Criteria:

  • A subarachnoid or intracerebral hemorrhage in the 60 days preceding the index procedure
  • A bleeding disorder or a platelet count of less than 100x103/mm3 or INR >1.5
  • A contraindication to or inability to tolerate antiplatelet therapy
  • An allergy to radiographic contrast agents
  • An allergy to  nickel, titanium, platinum, tungsten, or stainless steel
  • An allergy to local or general anesthesia
  • A history of untreated atrial fibrillation, untreated/uncontrollable hypertension, or other stroke risk factors
  • A history of deep vein thrombosis or pulmonary embolism
  • A history of heart failure, dilated cardiomyopathy, or congenital heart conditions
  • Hypercoagulopathy or a hemorrhagic or coagulation deficiency refractory to medical therapy or subject refuses treatment with blood products
  • Suffered a stroke within 180 days preceding the index procedure
  • Had major surgery within the 30 days preceding or planned for the 180 days following the index procedure, including but not limited to intracranial stenting or coiling
  • Target aneurysm has been previously treated with clipping, coiling, or flow diversion
  • Had previous stenting of or implant in parent artery proximal to the target aneurysm that could interfere with delivery or performance of study device
  • Asymptomatic extradural aneurysms requiring treatment
  • Contraindication to computed tomography (CT) or magnetic resonance (MR)
  • An unstable neurological deficit (i.e., worsening of a clinical condition within the 30 days preceding the index procedure)
  • Evidence of an active systemic infection (including COVID-19) at index procedure
  • Dementia or other cognitive condition limiting their ability to participate in the study
  • A condition that may limit survival to less than 12 months post-index procedure
  • Serum creatinine ≥2.5 mg/dL
  • Had radiation or chemotherapy treatment either currently or within the 60 days preceding the index procedure
  • Current enrollment in a separate clinical trial
  • Another condition(s) that, in the opinion of the Investigator, could interfere with the ability to perform a safe or effective procedure
  • Current pregnancy or plan to become pregnant within the 12 months following the index procedure, or be currently breastfeeding

Angiographic Exclusion Criteria:

  • Anatomy not amenable to endovascular treatment, including but not limited to severe vessel tortuosity or stenosis
  • Parent vessel stenosis is >50% in the target area
  • Extracranial stenosis of the carotid artery >50%
  • An intracranial mass
  • More than one vessel segment requiring IA treatment in the 12 months following the index procedure
  • Target aneurysm is mycotic or dissecting
  • Target aneurysm is at bifurcation
  • Target aneurysm will require coiling in addition to flow diversion, in Investigator's opinion

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: World Diverter Implantation
Device: Flow diverter implantation
Implantation of the World Diverter Embolization Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety - Major Adverse Events (MAEs)
Time Frame: 12 months

Composite incidence of the following events:

  • Major stroke (NIHSS increase of > 4) within 30 days post-procedure, defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting > 24 hours with no apparent cause other than of vascular origin, including ischemic stroke or hemorrhagic stroke [i.e., intraparenchymal hemorrhage (IPH), subarachnoid hemorrhage (SAH), subdural hemorrhage (SDH), epidural hemorrhage (EDH)] accompanied with radiological evidence
  • Major ipsilateral stroke within 12 months post-procedure, defined as a major stroke (as defined above) occurring within the vascular distribution of the target artery
  • Neurological death within 12 months, defined as a death which directly resulted from a neurologic cause.
12 months
Primary Effectiveness - Complete Occlusion
Time Frame: 12 months

The proportion of subjects with all of the following:

  • Complete (100%) occlusion of the target IA (Raymond-Roy Class I)
  • ≤ 50% stenosis of the parent artery at the target IA assessed by an independent Core Laboratory evaluation of angiography at 12 months post-procedure
  • No subsequent treatment of the target IA within 12 months post-procedure.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medium-Term Effectiveness
Time Frame: 6 months
Complete IA occlusion
6 months
Medium-Term Parent Artery Stenosis
Time Frame: 6 months
Parent Artery Stenosis
6 months
Medium-Term Functional Outcomes
Time Frame: 6 months
Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline
6 months
Secondary Effectiveness - Adequate Occlusion
Time Frame: 12 months

The proportion of subjects with all of the following:

  • Adequate occlusion of the target IA (Raymond-Roy Class I or II)
  • ≤ 50% stenosis of the parent artery at the target IA assessed by an independent Core Laboratory evaluation of angiography 12 months post-procedure
  • No subsequent treatment of the target IA within 12 months post-procedure
12 months
Long-Term Angiographic Outcome
Time Frame: 12 months
Raymond-Roy IA classifications
12 months
Long-Term Parent Artery Stenosis
Time Frame: 12 months
Parent Artery Stenosis
12 months
Long-Term Functional Outcome
Time Frame: 12 months
Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
World Medica USA, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alejandro Tomasello, MD, Hospital Vall d'hebrón

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-001WM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are protected by data privacy laws and are only provided for the purposes of this study following provision of participant informed consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings