Artisse™ Device for Brain Aneurysms

(ARTISSE Trial)

Recruiting at 15 trial locations

Overseen By Medtronic Neurovascular Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Neurovascular Clinical Affairs

Must not be taking: Anticoagulants

Disqualifiers: Systemic infection, Pregnancy, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: Procedure

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Artisse™ Intrasaccular Device to determine its safety and effectiveness in treating certain brain aneurysms, which are weak spots in blood vessels that can bulge and sometimes burst. The focus is on aneurysms that have either ruptured or are at risk due to their size and location. Participants should have a single brain aneurysm that is either causing issues or could do so in the future and must not have been previously treated with other devices. The trial seeks individuals with risk factors for aneurysm rupture, such as high blood pressure or a family history of similar issues. As an unphased trial, this study offers patients a unique opportunity to contribute to groundbreaking research in aneurysm treatment.

Will I have to stop taking my current medications?

The trial requires that participants stop taking anticoagulants (blood thinners) for at least 7 days after the procedure. If you are on such medications, you will need to discuss this with your doctor.

What prior data suggests that the Artisse™ Intrasaccular Device is safe for treating brain aneurysms?

Research has shown that the Artisse™ Intrasaccular Device holds promise for safely treating brain aneurysms. In earlier studies, patients successfully used and tolerated the device. For instance, one study found it effective in sealing aneurysms (weak spots in blood vessels) after 6 months, with good safety results. In Europe, many patients experienced successful treatments with the device, achieving a sealing rate of about 78% at 12 months and 79.2% at 36 months. These findings suggest that the Artisse™ Device is generally safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Artisse™ Intrasaccular Device because it offers a new way to treat brain aneurysms, especially those with wide necks at bifurcation points, which are challenging for current treatments like surgical clipping or coiling. Unlike these standard methods, which involve either clipping the aneurysm from the outside or inserting coils inside the aneurysm to promote clotting, Artisse™ is designed to be implanted endovascularly directly into the aneurysm sac. This targeted approach could potentially reduce the risk of recurrence and improve the overall safety and effectiveness of treating complex aneurysms.

What evidence suggests that the Artisse™ Device is effective for treating brain aneurysms?

Research has shown that the Artisse™ Intrasaccular Device effectively treats both unruptured and ruptured wide-neck brain aneurysms. In one study, the device was successfully implanted in 96.6% of cases, achieving proper placement in 98.7% of cases. The device is designed to completely seal the aneurysm, preventing further complications without additional treatment. Early results indicate that the device is safe and effective in initial procedures. These findings suggest that the Artisse™ Device could be a good option for individuals with this type of aneurysm. ^{1 2 4 6 7}

Who Is on the Research Team?

Harsh Sancheti

Principal Investigator

Medtronic

Are You a Good Fit for This Trial?

This trial is for adults over the age of 22 with a specific type of brain aneurysm that has not burst (unruptured) or has burst (ruptured). The aneurysms should be wide-necked and located at a point where two blood vessels split. Participants must agree to follow the study rules and provide written consent.

Inclusion Criteria

Subject is able to comply with all aspects of the Clinical Investigation Plan (CIP) requirements

Subject meets one or more risk factors for IA rupture

I or my legal representative have signed the consent form and HIPAA authorization.

Exclusion Criteria

Subject may need an adjunctive implant device in addition to the Artisse™ Intrasaccular Device during treatment planning

Subject is enrolled in another device or drug study that could confound study results

The Investigator determines that the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive endovascular implantation of the Artisse™ Intrasaccular Device for the treatment of wide-neck bifurcating intracranial aneurysms

Procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of aneurysm occlusion and clinical outcomes

5 years

Multiple visits over 5 years

Long-term follow-up

Participants are monitored for long-term safety and effectiveness, including incidence of retreatment and stroke

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Artisse™

Trial Overview The Artisse™ Intrasaccular Device, which is placed inside the aneurysm during a minimally invasive procedure, is being tested for its ability to safely and effectively treat brain aneurysms without requiring open surgery.

How Is the Trial Designed?

Group I: Artisse™ Intrasaccular Device Experimental Treatment 1 Intervention

Study subjects with an unruptured or ruptured wide-neck bifurcating intracranial aneurysm will be treated by endovascular implantation of the Artisse™ Intrasaccular Device.

Artisse™ is already approved in European Union, United States for the following indications:

Approved in European Union as Artisse Intrasaccular Device for:

• Unruptured and ruptured wide-neck bifurcating intracranial aneurysms

Approved in United States as Artisse Intrasaccular Device for:

• Unruptured and ruptured wide-neck bifurcating intracranial aneurysms

Who Is Running the Clinical Trial?

Medtronic Neurovascular Clinical Affairs

Lead Sponsor

Trials

32

Recruited

10,000+

Published Research Related to This Trial

The ARTISSE intrasaccular device was successfully deployed in all nine patients with bifurcation aneurysms, but only 66.7% achieved adequate aneurysm occlusion at 6 months, which decreased to 57.1% at 36 months, indicating modest long-term efficacy.

There were significant safety concerns, with 22.2% of patients experiencing major strokes related to the procedure, highlighting the need for careful patient selection and monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ARTISSE intrasaccular device for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results. Piotin, M., Fahed, R., Redjem, H., et al.[2022]

Intrasaccular flow diverters, particularly the Woven EndoBridge (WEB) device, have become important tools for treating complex wide-necked intracranial aneurysms, with the WEB being the only device approved by the FDA in the U.S.

Several other intrasaccular devices, such as the Luna/Artisse and Medina Embolic Systems, have received CE mark approval in Europe, indicating their safety and efficacy in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mini-review of intrasaccular flow diverters. Hecker, C., Broussalis, E., Griessenauer, CJ., et al.[2022]

The Medina® Embolization Device (MED) significantly reduces intra-aneurysmal flow velocity by an average of 33.6% after implantation, indicating its efficacy in disrupting blood flow in cerebrovascular aneurysms.

The study found that better coverage of the aneurysm neck by the MED correlates with greater flow disruption, suggesting that optimal device positioning is crucial for enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-aneurysmal flow disruption after implantation of the Medina® Embolization Device depends on aneurysm neck coverage. Frölich, AM., Nawka, MT., Ernst, M., et al.[2022]

Intrasaccular devices have been developed to improve treatment for intracranial aneurysms by providing easier navigation and deployment, especially for large and wide-neck aneurysms, which enhances the chances of successful long-term occlusion.

These devices occupy the aneurysm neck with better stability than traditional coiling methods and contain less metal, potentially reducing the risk of thromboembolic events compared to other treatments like flow diverters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review and journey in intrasaccular treatment of intracranial aneurysms. Islim, FI., Saleem, N., Patankar, T.[2023]

Three innovative intrasaccular devices (WEB®, Artisse™, and Contour Neurovascular System™) are being developed to treat wide-necked bifurcation aneurysms (WNBAs), each utilizing a fine mesh to promote blood stagnation and thrombosis for healing.

Recent studies show promising short-term success rates and safety profiles for these devices, indicating their potential effectiveness in treating challenging aneurysms as long-term occlusion rates are further evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new era in the treatment of wide necked bifurcation aneurysms: Intrasaccular flow disruption. Heiferman, DM., Goyal, N., Inoa, V., et al.[2022]

The Woven EndoBridge (WEB) device was successfully deployed in 98.5% of cases for treating 66 intracranial aneurysms in 63 patients, showing a high success rate in both ruptured and unruptured aneurysms.

At a mean follow-up of 9.1 months, 89.4% of treated aneurysms achieved complete occlusion, and 93.5% of patients maintained functional independence, indicating both safety and efficacy of the WEB device in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Woven EndoBridge Device for the Treatment of Intracranial Aneurysms: Initial Clinical Experience within an Australian Population. Gajera, J., Maingard, J., Foo, M., et al.[2022]

Citations

1. jnis.bmj.com jnis.bmj.com/content/early/2025/01/28/jnis-2024-022576

New Artisse intrasaccular device for intracranial aneurysm ... Results The Artisse device achieved an overall successful implantation rate of 96.6% (84/87), with satisfactory placement rates of 98.7% (74/75) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02998229

Study Details | NCT02998229 | The Artisse™ Intrasaccular ... The effectiveness of the Artisse™ Intrasaccular Device is measured by its ability to completely occlude the treated aneurysm without retreatment of the target ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39753340/

Artisse intrasaccular device for intracranial aneurysm ... The Artisse intrasaccular device (Medtronic) offers a novel treatment option for unruptured and ruptured wide-neck bifurcating intracranial aneurysms.

4. jnis.bmj.com jnis.bmj.com/content/16/Suppl_2/A13.1

procedural, safety and early effectiveness outcomes Conclusion Based on the updated clinical data, the Artisse device demonstrates procedural and early safety and promising results for effectiveness for the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12261992/

Intrasaccular therapy in wide-neck intracranial aneurysms Angiographic results post-procedure and in the follow-up are the main indices used to measure the efficacy of intrasaccular therapy.

6. europe.medtronic.com europe.medtronic.com/xd-en/healthcare-professionals/products/neurological/aneurysm-treatment/artisse.html

Aneurysm Treatment Products - Artisse Artisse™ is a flex-to-fit intrasaccular device that conforms to the shape of the aneurysm. Check the 12-month follow-up data ...

7. jnis.bmj.com jnis.bmj.com/content/early/2025/01/03/jnis-2024-022209

Artisse intrasaccular device for intracranial aneurysm ... 2 In Europe, an adequate occlusion rate of 78% at 12 months and 79.2% at 36 months follow-up has been shown.3 8 This video documents the ...