RECRUITING

Artisse™ Intrasaccular Device IDE

Conditions

Intracranial Aneurysm Intrasaccular Artisse

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Artisse™ Intrasaccular Device IDE

Quick Facts

Study Start:2024-04-16

Study Completion:2032-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02998229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	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.

Inclusion Criteria

Exclusion 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.
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.

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.

Contacts and Locations

Study Contact

Medtronic Neurovascular Clinical Affairs

CONTACT

949-837-3700

rs.nvclinicalartisse@medtronic.com

Study Locations (Sites)

Baptist Medical Center Jacksonville

Jacksonville, Florida, 32207

United States

Collaborators and Investigators

Sponsor: Medtronic Neurovascular Clinical Affairs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-16

Study Completion Date2032-02

Study Record Updates

Study Start Date2024-04-16

Study Completion Date2032-02

Terms related to this study

Keywords Provided by Researchers

Intracranial aneurysm
Intrasaccular
Artisse

Additional Relevant MeSH Terms

Intracranial Aneurysm