Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02998229
Other study ID # MDT24004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04870047 - Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation N/A
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT05665309 - Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor N/A
Completed NCT02783339 - Neuroform Atlas Stent for Intracranial Aneurysm Treatment
Withdrawn NCT01194388 - Axium Coil in Completing Endovascular Aneurysm Surgery Study
Completed NCT00071565 - Familial Intracranial Aneurysm Study II N/A
Recruiting NCT05409989 - MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study N/A
Completed NCT03680742 - Contour Neurovascular System - European Pre-Market Unruptured Aneurysm N/A
Completed NCT04872842 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
Terminated NCT02532517 - Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device N/A
Completed NCT03663257 - Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Recruiting NCT06189950 - Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE N/A
Recruiting NCT05608122 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)
Recruiting NCT03661463 - Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT). Phase 2
Completed NCT02609867 - A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise) N/A
Active, not recruiting NCT02292017 - Prospective Packing Density With Target Coils I N/A
Active, not recruiting NCT01872741 - Minipterional Versus Pterional Craniotomy N/A
Completed NCT00993057 - Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia Early Phase 1
Completed NCT00777088 - Pipeline for Uncoilable or Failed Aneurysms N/A
Completed NCT00777907 - Complete Occlusion of Coilable Aneurysms Phase 3