Intracranial AneurysmNCT07339358
Safety & Performance of the World Medica World Diverter Embolization Device
A study testing Flow diverter implantation in people with Intracranial Aneurysm, run by World Medica USA, LLC at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Flow diverter implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 31 Mar 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Flow diverter implantation
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow diverter implantationDevice
Implantation of the World Diverter Embolization Device
| Study group | Role | What they receive |
|---|---|---|
| World Diverter Implantation | Experimental | Not described Receives: Device: Flow diverter implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety - Major Adverse Events (MAEs)
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.
Measured: 12 months
Primary Effectiveness - Complete Occlusion
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.
Measured: 12 months
Secondary outcomes (7)
Medium-Term Effectiveness
Complete IA occlusion
Measured: 6 months
Medium-Term Parent Artery Stenosis
Parent Artery Stenosis
Measured: 6 months
Medium-Term Functional Outcomes
Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline
Measured: 6 months
Secondary Effectiveness - Adequate Occlusion
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
Measured: 12 months
Long-Term Angiographic Outcome
Raymond-Roy IA classifications
Measured: 12 months
Long-Term Parent Artery Stenosis
Parent Artery Stenosis
Measured: 12 months
Long-Term Functional Outcome
Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- World Medica USA, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alejandro Tomasello, MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339358
- Sponsor's protocol ID
- CIP-001WM
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Performance of the World Medica World Diverter Embolization Device
- ClinicalTrials.gov ID
- NCT07339358
- Acronym / sponsor ID
- CIP-001WM
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- World Medica USA, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| World Diverter Implantation | Experimental | Device: Flow diverter implantation |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow diverter implantationImplantation of the World Diverter Embolization Device | Device | World Diverter Implantation |
Primary outcome
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.
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.
7 secondary outcomes
Medium-Term Effectiveness
Time frame: 6 months
Medium-Term Parent Artery Stenosis
Time frame: 6 months
Medium-Term Functional Outcomes
Time frame: 6 months
Secondary Effectiveness - Adequate Occlusion
Time frame: 12 months
Long-Term Angiographic Outcome
Time frame: 12 months
Long-Term Parent Artery Stenosis
Time frame: 12 months
Long-Term Functional Outcome
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro Tomasello, MD principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow diverter implantation in people with Intracranial Aneurysm, run by World Medica USA, LLC at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety - Major Adverse Events (MAEs) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.