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The WEB®-IT China Clinical Study

China60 participantsStarted 2017-06-21

Plain-language summary

This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient whose age ≥ 18 and ≤75 years old * Patient must have a single ruptured or unruptured IA(intracranial aneurysm)requiring treatment * Patient must sign and date IRB/EC approved written informed consent prior to initiate of any study procedures Exclusion Criteria: * Patient has an IA with characteristics unsuitable for endovascular treatment * Patient has stroke-in-evolution within the prior 60-days * Patient has had an SAH(subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days * Patient's index IA was previously treated * Patient is pregnant

What they're measuring

Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis

Timeframe: 12 month

Primary Safety Endpoint: Proportion of death and major stroke

Timeframe: 12 month

Trial details

NCT IDNCT03207087

SponsorMicrovention-Terumo, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-30

View on ClinicalTrials.gov More Wide Neck Bifurcation Intracranial Aneurysms trials