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The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).

NCT02998229 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-05

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

Artisse™ Intrasaccular Device

Intrasaccular Device

Sponsors & Collaborators

  • Medtronic Neurovascular Clinical Affairs

    lead INDUSTRY

Principal Investigators

  • Harsh Sancheti · Medtronic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2027-08-31
Completion
2032-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02998229 on ClinicalTrials.gov