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New treatment option for Intracranial Aneurysm
Official title The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
ClinicalTrials.gov ID: NCT02998229
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent using the Institutional Review Board/Ethics...
- Subject is 18-75 years of age at the time of consent.
- 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...
- The target aneurysm must have the following characteristics:
- Saccular morphology
You likely can't join if
- During treatment planning, it is determined that subject may need an adjunctive implant device in addition to the Artisse™ Intrasaccular Device...
- Subject's target aneurysm was previously treated with other devices/implants (e.g., coils) or parent artery has a stent or other obstruction that...
- Subject has a known active systemic bacterial infection.
- Subject has anatomy or physiology considered unsuitable (e.g., vessel anomaly or disease) for endovascular treatment with the Artisse™ Intrasaccular...
- 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).
- Subject has an SAH from a non-target aneurysm or any other intracranial hemorrhage within 90 days.
See the full eligibility criteria
Who can join
- 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...
- Subject is 18-75 years of age at the time of consent.
- 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.
- The target aneurysm must have the following characteristics:
- Saccular morphology
- Located at a bifurcation in the anterior or posterior circulation
- Aneurysm Width appropriate for treatment with the Artisse™ Intrasaccular Device for device sizingper the Instructions for Use.
- Wide-necked, defined as neck size ≥ 4 mm and/or a dome-to-neck ratio of ≥ 1 and \< 2.
- 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...
- 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).
- 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...
- Treating physician has already selected the subject for endovascular treatment of the target aneurysm after considering risk-benefit of clipping vs endovascular treatment
- 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).
What rules you out
- During treatment planning, it is determined that subject may need an adjunctive implant device in addition to the Artisse™ Intrasaccular Device. (people who need unplanned adjunctive implant devices are not excluded.)
- 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...
- Subject has a known active systemic bacterial infection.
- 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.
- 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).
- Subject has an SAH from a non-target aneurysm or any other intracranial hemorrhage within 90 days.
- 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.
- Subject is enrolled in another device or drug study in which participation could confound study results.
- 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 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.
- 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.
- Subject has acute or chronic renal failure (unless on dialysis) that would prevent them from undergoing digital subtraction angiography (DSA).
- Subject has a life expectancy of less than 5 years due to an illness or condition other than the index IA.
The study team makes the final eligibility decision.
Where it's taking place
- Englewood, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Park Ridge, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Camden, New Jersey, United States
- Albany, New York, United States
- Buffalo, New York, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Greenville, South Carolina, United States
- Memphis, Tennessee, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Englewood, Colorado, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Park Ridge, Illinois, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.