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PICASSO: Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

  • Status
    Accepting Candidates
  • Age
    18 Years - 79 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

This study is being done to find the best possible approach to treat the narrowing or blockage in the blood vessels in the neck when there is an ischemic stroke. An ischemic stroke occurs when a brain vessel is blocked by a blood clot. The standard of care treatment of an ischemic stroke involves admitting the patients in the hospital and treating with medications including tissue plasminogen activator (tPA) or Tenecteplase (TNK), a drug given through the vein in arm that dissolves blood clots to restore the blood flow to the brain. Another treatment is to try to remove the clot with a device from the arteries in the brain. This will aim to reestablish blood flow to the brain and prevent further brain damage. This procedure is called mechanical thrombectomy. Concurrently, patients with narrowing of the carotid artery in the neck also require treatment. Currently, there are two types of approaches used by the treating physician, based on their preference. However, we do not know which technique is better. In the first approach, a device (stent) is placed to open the carotid artery during the mechanical thrombectomy procedure. This can be done either before removing the blood clot from the artery(ies) in the brain or after. The second approach involves placing a balloon to open the carotid artery and removing the brain blood clot. Both procedures require antiplatelet / anticoagulation medications.

Details

Protocol number 202401307

Eligibility

Inclusion Criteria:

1. 18 to 79 years of age 

  1. Presenting with symptoms consistent with AIS
  2. NIHSS ≥ 4
  3. Ability to randomize and start the endovascular therapy within 16 hours of stroke onset
  4. Pre-stroke mRS score 0-2
  5. Ability to obtain signed informed consent

    Exclusion Criteria:

    1. Known severe allergy to contrast media

  6. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) despite medication
  7. Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.

Lead researcher

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