Artisse™ Intrasaccular Device IDE

Intracranial Aneurysm Clinical Trial

— ARTISSE  

Official title:

Artisse™ Intrasaccular Device IDE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02998229
• Other study ID #: MDT24004
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2024
• Est. completion date: February 2032

Study information

• Verified date: April 2024
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: Medtronic Neurovascular Clinical Affairs
• Phone: 949-837-3700
• Email: rs.nvclinicalartisse[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The Artisse™ IDE study is a prospective, multi-center, single-arm Investigational Device Exemption (IDE) study of the Artisse™ Intrasaccular Device for the treatment of IAs. The primary objective of the Artisse™ IDE 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. The effectiveness of the Artisse™ Intrasaccular Device is measured by its ability to completely occlude the treated aneurysm without retreatment of the target aneurysm, recurrent subarachnoid hemorrhage from the target aneurysm, or significant parent artery stenosis (> 50% stenosis) at 1 year post-procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: February 2032
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 Diameter appropriate for treatment with the Artisse™ Intrasaccular Device per the Instructions for Use, between 3.4 mm and 6.0 mm.

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, presence of multiple IAs, and presence of concurrent pathology.

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 2 to 5) prior to presentation (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 breastfeeding at the time of admission or plans to become pregnant during their participation in the study.

8. Subject is enrolled in another device or drug study in which participation could confound study results.

9. The Investigator 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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Artisse™ Intrasaccular Device
Intrasaccular Device

Locations

Country	Name	City	State
United States	Baptist Medical Center Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness: Incidence of complete aneurysm occlusion	Incidence of complete aneurysm occlusion without retreatment of the target aneurysm, recurrent subarachnoid hemorrhage (SAH) from the target aneurysm, or significant parent artery stenosis (>50% stenosis) at 1 year post-procedure.	1 year post procedure
Primary	Safety: incidence of stroke	Incidence of all strokes (ischemic or hemorrhagic) or all neurological death within 1 year post-procedure.	1 year post procedure
Secondary	Incidence of implant success	Proportion of subjects with device implant success at the target site	Procedure
Secondary	Incidence of recurrence	Proportion of subjects with angiographic aneurysmal recurrence at 1 year post-procedure	1 year post procedure
Secondary	Incidence of stroke	Proportion of subjects experiencing a stroke (ischemic or hemorrhagic) within 30 days post-procedure, 180 days post-procedure, 3 years post-procedure, and 5 years post-procedure	30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Secondary	Change in Modified Rankin Score (mRS) compared to baseline. mRS scores can range from 0 (no symptoms) to 5 (severe disability) with a separate category of 6 added for patients who expire.	Proportion of subjects with unruptured intracranial aneurysms (IAs) experiencing improvement, deterioration, or no change in the mRS score compared to baseline through 30 days, 180 days, 1 year, 3 years, and 5 years post-procedure	30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Secondary	Incidence of good clinical outcomes in unruptured intracranial aneurysms (IAs)	Proportion of subjects with unruptured IAs experiencing good clinical outcomes, defined as an Modified Rankin Score (mRS) score of 0-2 (0: No symptoms, 1: No significant disability despite symptoms, 3: Slight disability) through 30 days post-procedure, 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure	30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Secondary	Incidence of good clinical outcomes in ruptured intracranial aneurysms (IAs)	Proportion of subjects with ruptured IAs experiencing good clinical outcomes, defined as an Modified Rankin Score (mRS) score of 0-2 (0: No symptoms, 1: No significant disability despite symptoms, 3: Slight disability) through 30 days post-procedure, 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure	30 days, 180 days, 1 year, 3 years, and 5 years post-procedure
Secondary	Incidence of adequate aneurysm occlusion	Incidence of adequate aneurysm occlusion of the target aneurysm at 180 days post-procedure, 1 year post-procedure, 3 years post-procedure, and 5 years post-procedure	180 days, 1 year, 3 years, and 5 years post-procedure
Secondary	Incidence of retreatment	Incidence of retreatment of the target aneurysm through 3 years post-procedure, and 5 years post-procedure	3 years and 5 years post-procedure