Artisse™ Device for Brain Aneurysms

(ARTISSE Trial)

Recruiting at 6 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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Artisse™ treatment for brain aneurysms?

The Artisse™ device is part of a new approach called intrasaccular flow disruption, which has shown promise in treating complex brain aneurysms by slowing blood flow into the aneurysm, promoting healing. Studies on similar devices, like the Woven EndoBridge, have demonstrated short-term success and safety, suggesting potential effectiveness for the Artisse™ device as well. ^{1 2 3 4 5}

How is the Artisse™ treatment different from other treatments for brain aneurysms?

The Artisse™ treatment is unique because it uses a fine mesh to disrupt blood flow within the aneurysm, promoting healing without placing a large amount of metal in the blood vessel, which may reduce the risk of blood clots compared to other methods. ^{1 3 4 5 6}

Research Team

Harsh Sancheti

Principal Investigator

Medtronic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A mini-review of intrasaccular flow diverters. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

The Woven EndoBridge Device for the Treatment of Intracranial Aneurysms: Initial Clinical Experience within an Australian Population. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The ARTISSE intrasaccular device for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A new era in the treatment of wide necked bifurcation aneurysms: Intrasaccular flow disruption. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intra-aneurysmal flow disruption after implantation of the Medina® Embolization Device depends on aneurysm neck coverage. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A review and journey in intrasaccular treatment of intracranial aneurysms. [2023]