The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs). (ARTISSE)

Artisse™ Intrasaccular Device IDE

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Artisse™ Intrasaccular Device

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Medtronic Neurovascular Clinical Affairs; Phone Number: 949-837-3700; Email: rs.nvclinicalartisse@medtronic.com

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113-2764
      • Recruiting
      • Swedish Medical Center
      • Contact: Ashley Thompson; Phone Number: (303) 907-5634; Email: ashley.thompson3@hcahealthcare.com
      • Principal Investigator: Ian Kaminsky, MD
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale New Haven Hospital
      • Principal Investigator: Charles Matouk, MD
      • Contact: Lindsey Fraczkiewicz; Email: lindsey.fraczkiewicz@yale.edu
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist Medical Center Jacksonville
      • Principal Investigator: Eric Sauvageau, MD
      • Contact: Smitha Gubbi, MD; Phone Number: 904-202-7069
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Principal Investigator: Maxim Mokin, MD
      • Contact: Muni Sai Bachalakuri; Phone Number: 813-844-8498; Email: mbachalakuri@tgh.org
  • Illinois
    • Chicago, Illinois, United States, 60673
      • Recruiting
      • University of Chicago
      • Principal Investigator: Tareq Kass-Hout, MD
      • Contact: Khalid Trad; Email: khalid.trad@bsd.uchicago.edu
    • Park Ridge, Illinois, United States, 60068
      • Recruiting
      • Advocate Lutheran General Hospital
      • Contact: Victor Arroyo; Phone Number: 847-723-7950; Email: victor.arroyo@aah.org
      • Principal Investigator: Demitrius Lopes, MD
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals and Clinics
      • Contact: Heena Olalde; Phone Number: 319-356-8326; Email: heena-olalde@uiowa.edu
      • Principal Investigator: Edgar Samaniego, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Shayna Hollander; Phone Number: (617) 643-5547; Email: sdhollander@mgh.harvard.edu
      • Principal Investigator: Aman B. Patel, MD
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper University Health
      • Principal Investigator: Daniel Tonetti, MD
      • Contact: Thuy Van Cao; Phone Number: (856) 342-2362; Email: cao-thuy@cooperhealth.edu
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: Alexandra Paul, MD
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Buffalo General Medical Center
      • Contact: Adnan Siddiqui, MD
    • New York, New York, United States, 10029
      • Recruiting
      • The Mount Sinai Hospital
      • Contact: Johanna Fifi, MD
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Principal Investigator: David Fiorella, MD
      • Contact: Marlene Baumeister; Phone Number: 631-444-1610; Email: marlene.baumeister@stonybrookmedicine.edu
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Recruiting
      • Novant Health Brain and Spine Surgery
      • Contact: Ziad Hage, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Contact: Heidi Poppendeck; Email: poppenh@ccf.org
      • Principal Investigator: Ashutosh Mahapatra, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Principal Investigator: Pascal Jabbour, MD
      • Contact: Nico Agosti; Email: nico.agosti@jefferson.edu
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Principal Investigator: Jan-Karl Burkhardt, MD
      • Contact: Christopher Boivin; Email: christopher.boivin@pennmedicine.upenn.edu
    • Pittsburgh, Pennsylvania, United States, 15213-2536
      • Recruiting
      • UPMC Presbyterian
      • Principal Investigator: Bradley Gross, MD
      • Contact: Lauren Puccio; Email: pucciolm@upmc.edu
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health
      • Contact: Mohammad Chaudry, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Semmes Murphy Clinic
      • Principal Investigator: Violiza Inoa, MD
      • Contact: Wendell Barnett; Phone Number: 901-260-6124; Email: wbarnett@semmes-murphey.com
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah Hospital
      • Contact: Ramesh Grandhi, MD
  • West Virginia
    • Morgantown, West Virginia, United States, 26506-9260
      • Recruiting
      • West Virginia University
      • Principal Investigator: Ansaar Rai, MD
      • Contact: Jennifer Domico; Phone Number: (304) 598-6930; Email: jennifer.domico@wvumedicine.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Width appropriate for treatment with the Artisse™ Intrasaccular Device for device sizingper the Instructions for Use.
   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 (or enhanced aneurysm walls on contrast), presence of multiple IAs, and presence of concurrent pathology.
8. Treating physician has already selected the subject for endovascular treatment of the target aneurysm after considering risk-benefit of clipping vs endovascular treatment
9. If the subject has an additional IA that was treated previously, the additional IA must have been clinically stable in the past 90 days (i.e. without ongoing adverse events related to the previous treatment).

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 3 to 5) prior to procedure (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 plans to become pregnant during the 1 year follow up period after the index procedure.
8. Subject is enrolled in another device or drug study in which participation could confound study results.
9. The treating physician 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Artisse™ Intrasaccular Device; Study subjects with an unruptured or ruptured wide-neck bifurcating intracranial aneurysm will be treated by endovascular implantation of the Artisse™ Intrasaccular Device.	Device: Artisse™ Intrasaccular Device; Intrasaccular Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Safety Evaluation	The safety of the Artisse™ Intrasaccular Device will be determined based on a review of all the serious adverse events (SAEs) observed during the study.	through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of implant success	Proportion of subjects with device implant success at the target site	Procedure
Incidence of recurrence	Proportion of subjects with angiographic aneurysmal recurrence at 1 year post-procedure	1 year post procedure
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
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
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
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
Incidence of stroke	Proportion of subjects experiencing a stroke (ischemic or hemorrhagic) within 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
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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Time of guiding catheter entry to the time of guiding catheter removal	at procedure
Radiation Exposure	dosage and cumulative fluoroscopy time	at procedure
Incidence of recurrence of the target aneurysm	Web Occlusion Grade C or D at any time after achieving a complete occlusion grade of A immediately post procedure	1 year post procedure
Incidence of retreatment		1 year post procedure
Incidence of aneurysm rupture		1 year post procedure
Incidence of intracranial hemorrhage (excluding target aneurysm)		1 year post procedure

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Investigators: Study Director: Harsh Sancheti, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2032

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimated): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Intracranial aneurysm; Intrasaccular; Artisse
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: MDT24004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No