Safety & Performance of the World Medica World Diverter Embolization Device

NCT ID: NCT07339358

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2028-08-31

Brief 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 terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.5 mm.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

World Diverter Implantation

Group Type: EXPERIMENTAL

Flow diverter implantation

Intervention Type: DEVICE

Implantation of the World Diverter Embolization Device

Interventions

Flow diverter implantation

Implantation of the World Diverter Embolization Device

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World Medica USA, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alejandro Tomasello, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Locations

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Countries

Spain

Other Identifiers

CIP-001WM

Identifier Type: -

Identifier Source: org_study_id