Brief Summary
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.
Brief Title
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
714-482-8074
Central Contact Email
amy.bowles@microvention.com
Completion Date
Completion Date Type
Estimated
Conditions
Wide Neck Bifurcation Intracranial Aneurysms
Eligibility Criteria
Key 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 IRN 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 other intracranial hemorrhage within 90 days
* Patient index IA was previously treated
* Patient is pregnant
* 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 IRN 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 other intracranial hemorrhage within 90 days
* Patient index IA was previously treated
* Patient is pregnant
Inclusion Criteria
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 IRN approved written informed consent prior to initiation of any study procedures
* 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 IRN approved written informed consent prior to initiation of any study procedures
Gender
All
Gender Based
false
Keywords
Aneurysm
Intracranial Arterial Disease
Cerebrovascular Disorders
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04839705
Org Class
Industry
Org Full Name
Microvention-Terumo, Inc.
Org Study Id
CL11010-001
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Primary Outcomes
Outcome Description
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Outcome Measure
Key Effectiveness Outcome
Outcome Time Frame
12 Months
Outcome Description
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
Outcome Measure
Key Safety Outcome
Outcome Time Frame
12 Months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Altschul
Investigator Email
daltschu@montefiore.org
Investigator Phone
718-920-7498