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Tests treatment safety and results for Acute Ischemic Stroke From Large Vessel Occlusion
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
- The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy (MT) using the ANA funnel catheter in its intended use, which is to facilitate the navigation and deployment of other neurovascular devices and to allow flow arrest during mechanical thrombectomy procedures performed in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) and treated within 24 hours of symptom onset.
- 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
- people who meet any of the exclusion criteria will be ineligible for participation in the study. The following exclusion criteria will be assessed...
- 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).
See the full eligibility criteria
Who can join
- 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.
- Imaging criteria:
- 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
What rules you out
- people who meet any of the exclusion criteria will be ineligible for participation in the study. The following exclusion criteria will be assessed pre-operatively:
- 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. Indicators of vessel tortuosity include but are not limited to the presence of carotid loops and type 3...
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include 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 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.