NCT04839705 · Microvention-Terumo, Inc.
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
(WEB PAS)
What this study is about
A forward-looking, conducted at multiple hospitals, single treatment group$1, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
View original scientific description
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
Interventions
DEVICE
WEB
Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. Other Names: • WEB Aneurysm Embolization Device
Primary outcome measures
Key Effectiveness Outcome
Time frame: 12 Months
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Key Safety Outcome
Time frame: 12 Months
Proportion of subjects with death of any nonaccidental cause or any major stroke\* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient must be ≥ 18 at the time of screening
- Patient must have a single ruptured or unruptured IA requiring treatment
- Patient must sign and date an IRB-approved written informed consent prior to initiation of any study procedures Key
Exclusion criteria
- Patient has an IA with characteristics unsuitable for endovascular treatment
- Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
- Patient has had an SAH from a non-index IA or any other intracranial hemorrhage within 90 days
- Patient's index IA was previously treated
- Patient is pregnant
Where
- Hollywood, Florida
- Orlando, Florida
- Honolulu, Hawaii
- Iowa City, Iowa
- Kansas City, Kansas
- Lexington, Kentucky
- Louisville, Kentucky
- Shreveport, Louisiana
- Baltimore, Maryland
- Boston, Massachusetts
- Worcester, Massachusetts
- Minneapolis, Minnesota
And 13 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2026 · Source of record for eligibility and locations