Pittsburgh, PANCT06370182Now EnrollingIRB Ready

Acute Ischemic Stroke From Large Vessel Occlusion Clinical Trial in Pittsburgh, PA

Access cutting-edge acute ischemic stroke from large vessel occlusion treatment through this clinical trial at a research site in Pittsburgh. Study-provided care at no cost to qualified participants.

Sponsored by Anaconda Biomed S.L.

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Expert Care in Pittsburgh

Access acute ischemic stroke from large vessel occlusion specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related acute ischemic stroke from large vessel occlusion treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Pittsburgh

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Pittsburgh site if eligible
  4. 4Begin participation

About This Acute Ischemic Stroke From Large Vessel Occlusion Study in Pittsburgh

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.

Sponsor: Anaconda Biomed S.L.

Who Can Participate

Inclusion Criteria

Subjects meeting all inclusion criteria 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. Subjects 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 subjects 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

Exclusion Criteria

Subjects 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 \<50 mg/dL or \>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 aortic arches.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT06370182) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Ischemic Stroke From Large Vessel Occlusion Treatment Options in Pittsburgh, PA

If you're searching for acute ischemic stroke from large vessel occlusion treatment options in Pittsburgh, PA, this clinical trial (NCT06370182) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute ischemic stroke from large vessel occlusion specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute ischemic stroke from large vessel occlusion clinical trials near you to find additional studies recruiting in your area.

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