Safety & Performance of the World Medica World Diverter Embolization Device

NCT07339358 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CIP-001WM
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Secondary Outcomes (7)

• Medium-Term Effectiveness

  6 months

• Medium-Term Parent Artery Stenosis

  6 months

• Medium-Term Functional Outcomes

  6 months

• Secondary Effectiveness - Adequate Occlusion

  12 months

• Long-Term Angiographic Outcome

  12 months

Study Arms (1)

World Diverter Implantation

EXPERIMENTAL

Device: Flow diverter implantation

Interventions

Flow diverter implantation DEVICE

Implantation of the World Diverter Embolization Device

World Diverter Implantation

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• World Medica USA, LLC: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alejandro Tomasello, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 14, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)