Results of the Use of Two Stentrievers Simultaneosly Compared With One as a Primary Treatment in Acute Ischemic Stroke
Launched by FUNDACIÓN EPIC · Jul 3, 2023
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new approach to treating acute ischemic stroke, which occurs when blood flow to the brain is blocked. The researchers are comparing the effectiveness of using two stentrievers (special devices that help remove blood clots) at the same time versus using just one. Previous studies have shown that using two stentrievers can lead to better results without increasing the risk of bleeding complications. This trial aims to see if this method can be safely used as the first choice of treatment for patients with a specific type of stroke.
To participate in this trial, individuals must be experiencing a new and disabling neurological problem that indicates a stroke. They should have a certain level of severity in their symptoms, measured by a scoring system called the NIHSS, and meet other specific criteria, such as having a certain score on a brain scan. Participants will receive treatment within 24 hours of their symptoms starting. If you or a loved one is interested in this trial, it's important to discuss eligibility and any concerns with a healthcare professional.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • A new disabling focal neurological deficit compatible with acute cerebral ischemia.
- • Any age. Informed consent obtained from the patient or representative.
- • NIHSS score ≥ 6.
- • Pre-existing functional clinical status less than or equal to 2 according to the mRS clinical scale.
- • Maximum time of 24 hours from symptom onset to arterial puncture. • TICI 0-1 in the diagnosed TICA (terminal internal carotid artery) , MCA (middle cerebral artery), and BA( basilar artery confirmed by angioCT and angiography).
- • ASPECTs score on baseline CT greater than or equal to 6.
- • In cases where it is indicated, prior intravenous fibrinolysis will be administered according to the protocols of each center.
- Exclusion Criteria:
- • Those described in the usual protocols for mechanical thrombectomy of each hospital.
- • Pre-existing functional clinical status greater than 2 according to the mRS clinical scale
- • Patients with tandem lesions of dissection or arteriosclerotic origin located in the extracranial internal carotid artery.
- • Initiation of treatment with a different technique than the one described.
- • Inability to use a proximal balloon guide catheter.
- • Use of aspiration catheter.
- • Intracranial atherosclerotic plaque as the cause of occlusion.
- • Advanced or terminal disease with a life expectancy of less than 6 months.
- • Patient who is participating in another study that may affect this one.
- • ASPECTS score less than or equal to 6 on baseline CT.
- • Evidence of significant hemorrhage or mass effect with midline shift on baseline CT.
- • Patients with occlusions in multiple vascular territories.
- • Evidence of intracranial tumor (except for small meningiomas)
About Fundación Epic
Fundación Epic is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a robust focus on improving patient outcomes, the foundation collaborates with healthcare professionals, research institutions, and industry partners to design and implement clinical studies across various therapeutic areas. Fundación Epic emphasizes ethical standards, scientific integrity, and patient safety, ensuring that all trials are conducted with the utmost care and rigor. Through its commitment to fostering cutting-edge research and promoting collaboration, Fundación Epic aims to contribute significantly to the development of new therapies and improve healthcare solutions globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Valladolid, , Spain
Oviedo, , Spain
Barakaldo, , Spain
Essen, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported