Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03553771 |
Recruitment Status :
Recruiting
First Posted : June 12, 2018
Last Update Posted : October 29, 2018
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Sponsor:
Microvention-Terumo, Inc.
Collaborator:
Clinact
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
Tracking Information | |||||||||
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First Submitted Date | May 16, 2018 | ||||||||
First Posted Date | June 12, 2018 | ||||||||
Last Update Posted Date | October 29, 2018 | ||||||||
Actual Study Start Date | February 7, 2018 | ||||||||
Estimated Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT03553771 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms | ||||||||
Official Title | A French, Multicenter, Prospective, Observational, "Real Life" Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms | ||||||||
Brief Summary | A French, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms | ||||||||
Detailed Description | This is a multicenter observational study. Treatment and follow-up visits will be done as per standard of care. The purpose of this study is to collect data on safety of the devices used since the French reimbursement. 130 patients will be enrolled over an 18-month recruitment period. All patients will be followed for at least 12 months. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | All patients with ruptured or not ruptured intracranial aneurysms treated with LVIS or LVIS Jr stent | ||||||||
Condition | Intracranial Aneurysm | ||||||||
Intervention | Device: LVIS and LVIS JR
Braided coil assist stents used for aneurysm embolization
Other Name: Low Profile Visualized Intraluminal Support
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Study Groups/Cohorts | Not Provided | ||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
130 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | April 1, 2022 | ||||||||
Estimated Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03553771 | ||||||||
Other Study ID Numbers | LEPI | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Microvention-Terumo, Inc. | ||||||||
Study Sponsor | Microvention-Terumo, Inc. | ||||||||
Collaborators | Clinact | ||||||||
Investigators |
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PRS Account | Microvention-Terumo, Inc. | ||||||||
Verification Date | October 2018 |