Using two stent retrievers at once versus one for treating acute ischemic stroke
Official title: A Randomized Study Comparing the Effectiveness and Security of the Use of Two Stentrievers Simultaneously Versus One Stentriever as a Primary Treatment in Acute Ischemic Stroke Patients.
Run by Fundación EPIC · NCT05930145 · Data updated 2026-11-12
We will test whether using two stent retrievers at the same time helps people with acute ischemic stroke get their blocked artery opened faster and recover better during mechanical thrombectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 4 sites (Essen and 3 other locations) |
| Status | Recruiting |
| Started | March 14, 2025 |
| Main results expected | September 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | July 28, 2025 |
| Trial ID | NCT05930145 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with a new disabling ischemic stroke due to a large-vessel occlusion (TICA, MCA, or BA), NIHSS ≥ 6, pre-stroke mRS ≤ 2, ASPECTS ≥ 6, and who can undergo arterial puncture within 24 hours of symptom onset.
✕Probably not a fit
Patients unlikely to benefit include those with pre-stroke disability (mRS > 2), tandem lesions from dissection or atherosclerosis, distal small-vessel occlusions, or other contraindications to mechanical thrombectomy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial compares simultaneous use of two stent retrievers versus a single stent retriever as the primary technique for endovascular thrombectomy in patients with acute large-vessel ischemic stroke. Eligible patients with disabling focal neurological deficits, NIHSS ≥ 6, ASPECTS ≥ 6, and target occlusions in the terminal internal carotid, middle cerebral, or basilar arteries within 24 hours of symptom onset are randomized to receive either double or single stent retriever treatment. The study measures first-pass reperfusion rates (eTICI 2c/3), technical and safety outcomes including hemorrhagic complications, and clinical functional outcomes at follow-up. Procedures are performed at participating tertiary centers with standardized thrombectomy protocols and core imaging assessment.
Why it matters
Potential benefit: If successful, the double stent retriever approach could increase first-pass complete reperfusion rates and improve functional recovery for patients undergoing mechanical thrombectomy.
How similar studies have gone: Observational series and a recent prospective clinical report have shown promising first-pass reperfusion rates and no clear increase in hemorrhagic complications with double stent retrievers, and in vitro randomized work supports their mechanical superiority, but large randomized clinical data remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Alfried Krupp Hospital Ruettenscheid
Essen, Germany Recruiting -
Hospital Universitario de Cruces
Barakaldo, Spain Recruiting -
Hospital Universitario Central de Asturias
Oviedo, Spain Recruiting -
Hospital Clínico Universitario de Valladolid
Valladolid, Spain Recruiting
Study contacts
- Study coordinator: PEDRO VEGA VALDES, MD, PhD
- Email: peveval@yahoo.es
- Phone: 0034985108000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
-
Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
-
Using AI to speed up transfers for stroke patients needing thrombectomy
This study tests if using an AI tool can help speed up the transfer of stroke patients to hospitals that can provide a special treatment called thrombectomy.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Web-based therapy using action observation and mirror therapy for arm weakness after stroke
This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
-
Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.