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Vascular Embolization Device

WEB Device for Brain Aneurysm (WEB PAS Trial)

N/A

Recruiting

Led By Adam Arthur, MD

Research Sponsored by Microvention-Terumo, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have a single ruptured or unruptured IA requiring treatment

Patient must be ≥ 18 at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

WEB PAS Trial Summary

This trialtests a new treatment for aneurysms in adults. Results will show if the treatment is effective in closing aneurysms after 1 year.

Who is the study for?

This study is for adults over 18 with brain aneurysms needing treatment, who can consent to participate. It's not for pregnant individuals, those with aneurysms unsuitable for endovascular treatment, high stroke risk patients, or anyone who had a recent subarachnoid hemorrhage from another aneurysm.Check my eligibility

What is being tested?

The trial tests the WEB Device's long-term safety and effectiveness in treating brain aneurysms. Participants will be observed to see if their aneurysm is adequately closed off at the one-year mark after receiving the device.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks may include complications related to endovascular procedures such as bleeding, infection at the entry site, or reactions to materials in the WEB Device.

WEB PAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have one aneurysm that needs treatment.

Select...

I am 18 years old or older.

WEB PAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Key Effectiveness Outcome

Key Safety Outcome

WEB PAS Trial Design

1Treatment groups

Experimental Treatment

Group I: WEB Aneurysm Embolization DeviceExperimental Treatment1 Intervention

WEB Aneurysm Embolization Device The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

WEB

2012

N/A

~5300

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Microvention-Terumo, Inc.Lead Sponsor

29 Previous Clinical Trials

6,101 Total Patients Enrolled

8 Trials studying Intracranial Aneurysms

918 Patients Enrolled for Intracranial Aneurysms

Adam Arthur, MDPrincipal InvestigatorMethodist University Hospital, Memphis TN

2 Previous Clinical Trials

350 Total Patients Enrolled

1 Trials studying Intracranial Aneurysms

150 Patients Enrolled for Intracranial Aneurysms

David Fiorella, MDPrincipal InvestigatorStony Brook University, Stony Brook NY

2 Previous Clinical Trials

350 Total Patients Enrolled

1 Trials studying Intracranial Aneurysms

150 Patients Enrolled for Intracranial Aneurysms

Media Library

WEB (Vascular Embolization Device) Clinical Trial Eligibility Overview. Trial Name: NCT04839705 — N/A

Intracranial Aneurysms Research Study Groups: WEB Aneurysm Embolization Device

Intracranial Aneurysms Clinical Trial 2023: WEB Highlights & Side Effects. Trial Name: NCT04839705 — N/A

WEB (Vascular Embolization Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04839705 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has this research project accepted thus far?

"Yes, the clinicaltrials.gov database confirms that this research project is still actively recruiting participants since first being posted on August 24th 2022; last edited January 23rd 2023. This trial requires 180 individuals at two different sites."

Answered by AI

Is this investigation recruiting participants at present?

"Data hosted on clinicaltrials.gov reveals that this medical trial is now open for recruitment. It was first announced on August 24th 2022 and further revised on January 23rd 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device

2022. "Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04839705.