Acute Ischemic Stroke From Large Vessel Occlusion study: ANA Funnel Catheter
Official title Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter
ClinicalTrials.gov ID: NCT06370182
What this study is testing
- What it's testing
- This study checks if the ANA funnel catheter is safe and works well when used to help remove blood clots during stroke treatment.
- Who it's for
- People who have had a severe stroke caused by a blockage in a large artery and are being treated within 24 hours of symptoms starting.
- What's involved
- Participants will receive a procedure to remove a blood clot using the new catheter to help guide other medical tools.
- Time commitment
- The study involves the stroke treatment procedure and follow-up checks to monitor safety and results.
Which group you join is decided by chance.
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 85
You may be able to join if
- Key people meeting all will be considered for enrollment in the study.
- Age 22 to 85 years.
- Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points.
You likely can't join if
- Subject was diagnosed with a stroke in the past year.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Known hemorrhagic diathesis, coagulation factor deficiency, oral anticoagulant therapy with antivitamin K, with INR \>3.0, or thrombocytopenia -...
- Known baseline glucose of \ 400 mg/dL.
- Severe, sustained uncontrolled hypertension refractory to treatment (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
- Serious, advanced, or terminal disease with anticipated life expectancy of less than 1 year.
See the full eligibility criteria
- Key people meeting all will be considered for enrollment in the study.
- Age 22 to 85 years.
- Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points.
- Pre-ictal mRS score of 0,1 or 2.
- Treatable within 16 hours of symptom onset, defined as point in time when the subject was last observed to be asymptomatic; treatment start is defined by arterial puncture time.
- If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. people eligible for IV thrombolysis should receive it without delay.
- Occlusion (eTICI ≤ 1 flow) of the terminal carotid artery, middle cerebral artery M1 segment or, dominant or proximal M2 segment, indicated for mechanical thrombectomy, confirmed with conventional angiography or CTA/MRA.
- Perfusion weighted criterion: volume of diffusion restriction visually assessed ≤ 50 mL on CTP/MRP, or
- CT criterion: Alberta Stroke program early CT score (ASPECTS) 6 to 10 on baseline CT/DWI-MRI. (Inclusion of people with ASPECTS 5 is permitted at centers performing scoring on MRI)
- The subject is indicated for a neurovascular thrombectomy procedure with an approved stent retriever per its Instructions for Use. Key
- Subject was diagnosed with a stroke in the past year.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Known hemorrhagic diathesis, coagulation factor deficiency, oral anticoagulant therapy with antivitamin K, with INR \>3.0, or thrombocytopenia - baseline platelet count \< 50,000 platelets/mL.
- Known baseline glucose of \ 400 mg/dL.
- Severe, sustained uncontrolled hypertension refractory to treatment (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
- Serious, advanced, or terminal disease with anticipated life expectancy of less than 1 year.
- Known cancer with metastases.
- History of life-threatening allergy (more than rash) to contrast medium.
- Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) \<30 mL/min.
- Subject is a current user or has a recent history of cocaine \&/or heroin use.
- Known pregnancy and/or lactating female.
- Subject is participating in a concurrent study involving an investigational drug or device that would impact the primary endpoint of this study.
- Subject is unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas, etc.)
- CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
- Significant mass effect with midline shift.
- Evidence of intracranial tumor (except asymptomatic meningioma of ≤ 2cm in diameter).
- Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
- History of preexisting stent proximal to or at the occlusion site that may preclude safe deployment or recovery of the stent retriever.
- Vessel tortuosity too difficult to allow endovascular access of the intracranial ICA per investigator judgement.
The study team makes the final eligibility decision.
Where it is enrolling
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Park Ridge, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Buffalo, New York, United States
- New York, New York, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Milwaukee, Wisconsin, United States
- Montpellier, France
- Paris, France
- Suresnes, France
- Toulouse, France
- Budapest, Hungary
- Barcelona, Spain
- Madrid, Spain
- Murcia, Spain
- Oviedo, Spain
+ 1 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, 22 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Jacksonville, Florida, United States; Atlanta, Georgia, United States; Park Ridge, Illinois, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States; Buffalo, New York, United States and 15 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.