Intracranial Aneurysm
Conditions
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.
Interventions
Implantation of the World Diverter Embolization Device
Sponsors
World Medica USA, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety - Major Adverse Events (MAEs) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medium-Term Functional Outcomes | 6 months | Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline |
| Secondary Effectiveness - Adequate Occlusion | 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 |
| Medium-Term Effectiveness | 6 months | Complete IA occlusion |
| Long-Term Parent Artery Stenosis | 12 months | Parent Artery Stenosis |
| Long-Term Functional Outcome | 12 months | Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline |
| Long-Term Angiographic Outcome | 12 months | Raymond-Roy IA classifications |
| Medium-Term Parent Artery Stenosis | 6 months | Parent Artery Stenosis |
Countries
Spain
Outcome results
None listed