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Treatment of wide-neck bifurcating intracranial aneurysms using the Artisse™ device

Artisse™ Intrasaccular Device IDE

Not applicable Interventional Medtronic Neurovascular Clinical Affairs · NCT02998229

This study is testing a new device called Artisse™ to see if it can safely and effectively treat wide-neck bifurcating brain aneurysms, both those that have and haven't ruptured.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorMedtronic Neurovascular Clinical Affairs Industry-sponsored
Locations22 sites (Englewood, Colorado and 21 other locations)
Trial IDNCT02998229 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Artisse™ Intrasaccular Device for treating both unruptured and ruptured wide-neck bifurcating intracranial aneurysms. It is a prospective, multi-center, single-arm Investigational Device Exemption (IDE) study that aims to determine the device's ability to completely occlude the aneurysm without the need for retreatment or causing significant complications. The primary outcomes will be assessed one year after the procedure, focusing on the device's performance in preventing recurrent hemorrhage and significant artery stenosis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a single unruptured or ruptured wide-neck bifurcating intracranial aneurysm requiring treatment.

Not a fit: Patients with multiple aneurysms requiring treatment within a year or those with aneurysms outside the specified size and morphology criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could provide a safer and more effective treatment option for patients with wide-neck bifurcating intracranial aneurysms.

How similar studies have performed: Other studies have shown promising results with similar intrasaccular devices, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent using the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form (ICF). Health Insurance Portability and Accountability Act (HIPAA)/data protection authorization has been provided and signed by the subject or subject's LAR.
2. Subject is 18-75 years of age at the time of consent.
3. Subject has a single unruptured or ruptured IA requiring treatment. If the patient has an additional IA, the additional IA must not be deemed to require treatment within 1-year of the index procedure.
4. The target aneurysm must have the following characteristics:

   1. Saccular morphology
   2. Located at a bifurcation in the anterior or posterior circulation
   3. Aneurysm Width appropriate for treatment with the Artisse™ Intrasaccular Device for device sizingper the Instructions for Use.
   4. Wide-necked, defined as neck size ≥ 4 mm and/or a dome-to-neck ratio of ≥ 1 and \< 2.
5. If the target aneurysm was acutely ruptured, subject must be neurologically stable with Hunt and Hess Grade of I or II.

   Ruptured IA is defined as showing evidence of SAH attributed to the target aneurysm within the last 30-days (using computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP).)
6. Subject is able to comply with all aspects of the Clinical Investigation Plan (CIP) requirements (e.g., screening, evaluation, treatment, and the post-procedure follow-up schedule).
7. Subject meets one or more risk factors for IA rupture, such as age, hypertension, cigarette smoking, use of sympathomimetic drugs, Japanese or Finnish ancestry, history of prior aneurysmal subarachnoid hemorrhage (aSAH), familial intracranial aneurysms or SAH, clinical or radiological mass effect, reduced quality of life due to fear of rupture, IA size, location, and morphology, documented growth of IA on serial imaging (or enhanced aneurysm walls on contrast), presence of multiple IAs, and presence of concurrent pathology.
8. Treating physician has already selected the subject for endovascular treatment of the target aneurysm after considering risk-benefit of clipping vs endovascular treatment
9. If the subject has an additional IA that was treated previously, the additional IA must have been clinically stable in the past 90 days (i.e. without ongoing adverse events related to the previous treatment).

Exclusion Criteria:

1. During treatment planning, it is determined that subject may need an adjunctive implant device in addition to the Artisse™ Intrasaccular Device. (Subjects who need unplanned adjunctive implant devices are not excluded.)
2. Subject's target aneurysm was previously treated with other devices/implants (e.g., coils) or parent artery has a stent or other obstruction that could interfere with the correct placement of the Artisse™ Intrasaccular Device.
3. Subject has a known active systemic bacterial infection.
4. Subject has anatomy or physiology considered unsuitable (e.g., vessel anomaly or disease) for endovascular treatment with the Artisse™ Intrasaccular Device by the treating physician.
5. Subject has a mRS score \> 2 (i.e., mRS scores of 3 to 5) prior to procedure (in case of unruptured IA) or prior to rupture (in case of ruptured IA).
6. Subject has an SAH from a non-target aneurysm or any other intracranial hemorrhage within 90 days.
7. Subject, of child-bearing potential, is pregnant (confirmed with a positive pregnancy test) or plans to become pregnant during the 1 year follow up period after the index procedure.
8. Subject is enrolled in another device or drug study in which participation could confound study results.
9. The treating physician determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke) may be compromised by the subject's enrollment.
10. Subject has a known hypersensitivity, which cannot be medically treated, to any component of the study device, procedural materials, or medications commonly used during the procedure.
11. Subject is taking anticoagulants (e.g., warfarin) that cannot be discontinued for a minimum of 7 days post-procedure or have a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
12. Subject has acute or chronic renal failure (unless on dialysis) that would prevent them from undergoing digital subtraction angiography (DSA).
13. Subject has a life expectancy of less than 5 years due to an illness or condition other than the index IA.

Where this trial is running

Englewood, Colorado and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intracranial AneurysmIntracranial aneurysmIntrasaccularArtisse
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.