Safety & Performance of the World Medica World Diverter Embolization Device
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 80 years old?
Source: NCT07339358, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- World Medica USA, LLC
- Trial code
- NCT07339358
- Record updated
- 14 January 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: A contraindication to or inability to tolerate antiplatelet therapy; Hypercoagulopathy or a hemorrhagic or coagulation deficiency refractory to medical therapy or subject refuses treatment with blood products; 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; Had radiation or chemotherapy treatment either currently or within the 60 days preceding the index procedure; A subarachnoid or intracerebral hemorrhage in the 60 days preceding the index procedure; 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; Suffered a stroke within 180 days preceding the index procedure; 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; Another condition(s) that, in the opinion of the Investigator, could interfere with the ability to perform a safe or effective procedure; A bleeding disorder or a platelet count of less than 100x103/mm3 or INR >1.5; Serum creatinine ≥2.5 mg/dL; Asymptomatic extradural aneurysms requiring treatment; Contraindication to computed tomography (CT) or magnetic resonance (MR); Current enrollment in a separate clinical trial; 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.