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New treatment option for Intracranial Aneurysm
Official title Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)
ClinicalTrials.gov ID: NCT07225075
What this study is testing
- What it's testing
- The PIONEER Study is a pivotal, multi-center, prospective, single-arm study designed to evaluate the safety and efficacy of the Silk Vista Baby (SVB) Flow Diverter for the treatment of unruptured aneurysms.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- Age 22 to ≤ 80 years old
- Participant has a single target unruptured intracranial aneurysm (IA) originating from a parent vessel of 1.5 mm to 3.4mm in diameter located at or...
- Participant has a target saccular or fusiform IA with an aneurysm neck ≥ 4mm or a dome to neck ratio \<2
- Participant has a target IA that is ≤ 12 mm
- Participant meets one or more risk factors for IA rupture, such as age (≤70); hypertension; cigarette smoking; use of sympathomimetic drugs; Japanese...
You likely can't join if
- Target aneurysm is unsuitable for flow diverter treatment
- Subject requires more than one flow diverter for target aneurysm treatment
- Has vessel characteristics, such as severe tortuosity, stenosis, atherosclerotic disease, or morphology that would preclude safe endovascular access...
- Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
- Has a medical contraindication to study or procedure-related antiplatelet/anticoagulation medications (e.g., aspirin, clopidogrel/Plavix, ticagrelor...
- Has a known severe allergy to nickel, titanium or platinum
See the full eligibility criteria
Who can join
- Age 22 to ≤ 80 years old
- Participant has a single target unruptured intracranial aneurysm (IA) originating from a parent vessel of 1.5 mm to 3.4mm in diameter located at or distal to the ICA terminus or in SVB-amenable anterior or posterior...
- Participant has a target saccular or fusiform IA with an aneurysm neck ≥ 4mm or a dome to neck ratio \<2
- Participant has a target IA that is ≤ 12 mm
- Participant meets one or more risk factors for IA rupture, such as age (≤70); hypertension; cigarette smoking; use of sympathomimetic drugs; Japanese or Finnish ancestry; history of prior aneurysmal subarachnoid...
- Participant has pre-procedure (obtained up to 14 days prior to the procedure day) PRU value between 60-200
- Participant or a legally authorized representative (LAR) provides written informed consent using the IRB/REB-approved consent form and agrees to comply with protocol follow-up and requirements
What rules you out
- Target aneurysm is unsuitable for flow diverter treatment
- Subject requires more than one flow diverter for target aneurysm treatment
- Has vessel characteristics, such as severe tortuosity, stenosis, atherosclerotic disease, or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
- Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
- Has a medical contraindication to study or procedure-related antiplatelet/anticoagulation medications (e.g., aspirin, clopidogrel/Plavix, ticagrelor, Prasugrel, Gp IIb/IIIa inhibitors, heparin, etc.), local or general...
- Has a known severe allergy to nickel, titanium or platinum
- Modified Rankin Score (mRS) assessment is ≥ 3 at screening or pre-procedure mRS could not be assessed
- The health of the participant or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the participant's enrollment
- Subarachnoid hemorrhage occurred within 30 days prior to enrollment
- Intracranial parenchymal hemorrhage occurred within 60 days prior to enrollment
- Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after treatment date
- Has more than one IA that requires treatment within 120 days of treatment date
- Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
- Requires adjunctive coiling during SVB procedure
- Chronic anticoagulation therapy is ongoing or known coagulopathy exists
- Has other known serious concurrent medical conditions such as active bacterial infection, heart disease (including atrial fibrillation, pacemaker, recent myocardial infarction [\ 2.0mg/dl serum creatinine) or any other...
- Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
- Unable to complete study follow-up due to dementia or psychiatric disorder, substance abuse, or history of noncompliance with medical advice
- Women who are pregnant or nursing at the time of enrollment or women who wish to become pregnant during the length of study participation
- Presence of intracranial mass (tumor, except meningioma that doesn't require surgery for 1 year) or non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
- Participation in any other investigational study which can influence collection of valid data under this study
The study team makes the final eligibility decision.
Where it's taking place
- Thousand Oaks, California, United States
- Jacksonville, Florida, United States
- Toronto, Ontario, Canada
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, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thousand Oaks, California, United States; Jacksonville, Florida, United States; Toronto, Ontario, Canada. 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.