Trenza Embolization Device for Intrasaccular Aneurysm Treatment
Sponsor
Stryker Neurovascular (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04380350
Collaborator
(none)
106
1
44.5
2.4
Study Details
Study Description
Brief Summary
The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
Prospective, multi-center, single-arm, post-market follow-up study conducted in Europe for the treatment of patients with saccular intracranial aneurysms.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
106 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Trenza Embolization Device for Intrasaccular Aneurysm Treatment
Actual Study Start Date
:
Dec 17, 2020
Anticipated Primary Completion Date
:
Mar 1, 2024
Anticipated Study Completion Date
:
Sep 1, 2024
Outcome Measures
Primary Outcome Measures
- Safety primary outcome measure [1 year (± 6 months)]
Stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery, occurring within 12 months post-procedure
- Effectiveness primary outcome measure [1 year (± 6 months)]
Adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis) using Raymond Roy classification
Secondary Outcome Measures
- Safety secondary outcome measure [1 year (± 6 months)]
Any stroke event occurring through 12 months post-procedure
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
- Has a single, target intracranial aneurysm that is suitable for endovascular treatment.
Exclusion Criteria:
- Target aneurysm has been previously treated
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hopital Purpan | Toulouse | France |
Sponsors and Collaborators
- Stryker Neurovascular
Investigators
- Principal Investigator: Christophe Cognard, Pr, Hospital Purpan, Toulouse, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT04380350
Other Study ID Numbers:
- TREAT
First Posted:
May 8, 2020
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: