Health TrialsbyHealthPanel

Safety & Performance of the World Medica World Diverter Embolization Device

ConditionIntracranial Aneurysm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-80
SponsorWorld Medica USA, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Flow diverter implantation

    Device

    Implantation of the World Diverter Embolization Device

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: World Diverter ImplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months

Secondary outcomes

1

Medium-Term Effectiveness

Complete IA occlusion

Time frame
6 months
2

Medium-Term Parent Artery Stenosis

Parent Artery Stenosis

Time frame
6 months
3

Medium-Term Functional Outcomes

Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline

Time frame
6 months
4

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

World Medica USA, LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: