Clinical trial Recruiting at 4 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorFundación EPIC
Academic / other
Locations4 sites (Essen and 3 other locations)
StatusRecruiting
StartedMarch 14, 2025
Main results expectedSeptember 1, 2026
Study endsOctober 1, 2026
Registry record updatedJuly 28, 2025
Trial IDNCT05930145 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.