Hemorrhagic Stroke study: Flow diversion
Official title The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
ClinicalTrials.gov ID: NCT07143019
What this study is testing
- What it's testing
- The study aims to determine how safe and effective the device is for treating wide‑necked intracranial aneurysms.
- Who it's for
- The study looks for patients who have wide‑necked aneurysms in the brain.
- What's involved
- Participants will receive the device during a minimally invasive procedure and will have follow‑up visits and tests to monitor safety and outcomes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is ≥ 18 years
- Subject has a mRS ≤2 before the index procedure
- Saccular or fusiform morphology
- Located in the internal carotid artery and its branches
- Aneurysm neck ≥4 mm or dome-to-neck ratio \<2
You likely can't join if
- Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
- Any other known IA requiring treatment within 3 months post-procedure
- Subarachnoid hemorrhage in the past 30 days prior to the index procedure
- Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
- Anatomy unsuitable for endovascular procedure due to severe vessel tortuosity or stenosis, or stented ipsilateral carotid artery within 3 months...
- Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm
See the full eligibility criteria
- Subject is ≥ 18 years
- Subject has a mRS ≤2 before the index procedure
- Saccular or fusiform morphology
- Located in the internal carotid artery and its branches
- Aneurysm neck ≥4 mm or dome-to-neck ratio \<2
- Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA
- Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.
- Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
- Any other known IA requiring treatment within 3 months post-procedure
- Subarachnoid hemorrhage in the past 30 days prior to the index procedure
- Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
- Anatomy unsuitable for endovascular procedure due to severe vessel tortuosity or stenosis, or stented ipsilateral carotid artery within 3 months prior to the index procedure
- Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm
- Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date
- Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
- Known serious sensitivity to radiographic contrast agents that cannot be managed medically
- Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components
- Irreversible bleeding disorder and/or signs of active bleeding at subject presentation
- Known renal failure with a serum creatinine \>2.5 mg/dl (or 220 μmol/l) not on dialysis
- Contraindication to CT scan, MRI, or angiography
- Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)
- Known coagulopathy, or an admission International Normalized Ratio \>3.0 without oral anticoagulation therapy, or an admission platelet count of \<100000
- Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial
- Unable to complete the required study follow-ups
- Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)
- Participating in another clinical trial that could affect participation or primary outcomes of this study
- Women currently pregnant or wish to become pregnant during the study or breast feeding.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Englewood, Colorado, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Park Ridge, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- Manhasset, New York, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Greenville, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
+ 4 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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Englewood, Colorado, United States; Jacksonville, Florida, United States and 18 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.