Using two stent retrievers at once versus one for treating acute ischemic stroke

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.

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

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación EPIC (other)
• Locations: 4 sites (Essen and 3 other locations)
• Trial ID: NCT05930145 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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)

Where this trial is running

Essen and 3 other locations

• 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

Conditions: Stroke, Thrombectomy, Arterial Occlusive Diseases, Double Stentriever