European, Multi-center, Exploratory Trial to Assess WEB V... | NCT06511245

Studies
European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.

NCT06511245

Sponsor

Microvention-Terumo, Inc.

Status

Recruiting

Last Update Posted

Dec 18, 2024Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Ruptured Aneurysm

Interventions

Randomisation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CIP EMEA 23-01	Other Identifier	Sponsor ID

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2024Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Jun 26, 2024

First Submission Date that Met QC Criteria

Jul 15, 2024

First Posted Date

Jul 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2024

Last Update Posted Date

Dec 18, 2024Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Label	Type	Description	Intervention Names
WEB	Other		Other: Randomisation
Other endovascular techniques	Other		Other: Randomisation

Name	Type	Description	Arm Group Labels	Other Names
Randomisation	Other	Technique assigned through randomization	Other endovascular techniques WEB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
As exploratory design, one of the outcome will be the assessment of aneurysm occlusion at 12 months using Raymond-Roy scale.	Raymond-Roy Classification is an angiographic classification including 3 classes, from class 1 (complete obliteration) to class 3 (aneurysm remnant).	12 months (-3/+6 months)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Patient is above 18 years of age at the time of consent
Patient has an identified acutely ruptured intracranial aneurysm requiring endovascular treatment (for the purposes of this study an acutely ruptured IA patient is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days)
Aneurysm dome diameter must be ≤ 10mm and within the diameter (and parent vessel diameter, as appropriate) range treatable by commercially available WEB devices as well as at least one other alternative commercially available endovascular treatment device used per hospital standard practice
Aneurysm is located on the anterior communicating artery complex segment (ACom), internal carotid artery terminus (ICAt), anterior cerebral artery (ACA), middle cerebral artery (MCA), basilar apex, posterior communicating artery (PCom) or pericallosal artery
Patient must be neurologically stable with a Hunt & Hess score of I to III
Patient or patient's legally authorized representative (LAR) has provided written informed consent

Main Exclusion Criteria:

Aneurysm to be treated is unsuitable for endovascular treatment with commercially available WEB devices and/or all other available endovascular treatment techniques used per standard site practice
Patient presenting as target aneurysm a blister like or dissecting aneurysm
Patient has more than one aneurysm requiring treatment within 30 days of completion of treatment of the target aneurysm
Patient with multiple aneurysms in whom ruptured aneurysm cannot be identified
Patient has pre-morbid mRS > 2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases