Safety and Effectiveness Analysis of Stent Assisted Coiling With LVIS™ Evo™ and HydroCoil® Embolic System in Aneurysm Treatment

Microvention-Terumo, Inc.19 sites in 5 countries206 target enrollmentJanuary 14, 2022

ConditionsIntracranial Aneurysm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intracranial Aneurysm
Sponsor: Microvention-Terumo, Inc.
Enrollment: 206
Locations: 19
Primary Endpoint: Proportion of aneurysms with complete occlusion
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective and safe when assessed at 1 year after the procedure

Detailed Description

Patient treatment and follow-up will be performed as per standard of care. The study will evaluate the proportion of aneurysms with complete occlusion based on Raymond-Roy occlusion classification (RROC) at 12 ± 6-months, as well as other effectiveness and safety endpoints such as the occurence of stent stenosis or parent artery occlusion, the occurence of retreatment and recanalization, the rate of major ipsilateral stroke or neurological death, the proportion of patients with good functional clinical outcome, the occurence of SAH, aneurysm rupture, procedural complications, serious adverse events... Sample size: 200 patients

Registry

clinicaltrials.gov

Start Date

January 14, 2022

End Date

December 1, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Microvention-Terumo, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient whose age is 18 years old or above;
•Patient (or legal representative, where applicable) who understands the study requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed;
•Patient eligible for the treatment with LVIS™ Evo™ and HydroCoil® Embolic System (HES);
•Patient whose target aneurysm is unruptured or ruptured (\> 30 days since occurrence);
•Patient whose target aneurysm size is less than or equal to 12 mm;
•Patient willing to comply with all planned follow-ups and evaluations.

Exclusion Criteria

•EC 1 Patient who has suffered an intracerebral hemorrhage within 30 days prior to the procedure;
•Patient whose target aneurysm is a fusiform aneurysm;
•Patient whose target aneurysm has previously been treated with a stent;
•Patient whose target aneurysm is partially thrombosed;
•Patient whose target aneurysm requires Y stenting;
•Patient whose target aneurysm is associated with an arteriovenous malformation (cAVM), or any other lesion that could lead to hemorrhagic complications;
•Patient who has more than one aneurysm to be treated during the same procedure, (except in case of an adjacent aneurysm that could be treated with the same stent);
•Patient for whom the treatment with another stent than LVIS™ Evo™ or in addition to LVIS™ Evo™ is planned;
•Patient with a planned treatment of other aneurysm in the same vascular territory within 12 months;
•Patient who has a known allergy to contrast agents (that cannot be adequately premedicated) and/or to the study device or procedure-required concomitant medications or procedures (e.g. contraindication to antiplatelet and/or anticoagulants, allergy to Nickel-titanium or contraindication to MRI/MRA or angiography);

Outcomes

Primary Outcomes

Proportion of aneurysms with complete occlusion

Time Frame: 12 ± 6-month

based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory using digital subtraction angiograms (DSA)

Secondary Outcomes

RROC shift between immediate post procedure and each follow-up visit(30 ± 6 months)
Percentage of HES coil length implanted in the target aneurysm(Day 0)
Aneurysm occlusion stability between immediate post procedure and each follow-up visit(30 ± 6 months)
Occurrence of target aneurysm recanalization at each follow-up(30 ± 6 months)
Occurrence of procedural complications(Day 0)
Proportion of patients with good functional clinical outcomes(30 ± 6 months)
Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III, and Modified Raymond-Roy Classification at immediate post procedure and each follow-up visits(30 ± 6 months)
Occurrence of in-stent stenosis or parent artery occlusion at each follow-up(30 ± 6 months)
Major ipsilateral stroke or neurological death within 12 months and 30 months(30 ± 6 months)
All-cause mortality rate(30 ± 6 months)
Proportion of aneurysms with stent successful deployment at the target aneurysm neck(Day 0)
Proportion of aneurysms with complete stent apposition(Day 0)
Occurrence of target aneurysm retreatment at each follow-up(30 ± 6 months)
Occurrence of subarachnoid hemorrhage(30 ± 6 months)
Occurrence of Aneurysm rupture(30 ± 6 months)
Occurrence of device-related serious adverse events(30 ± 6 months)