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.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Several studies have demonstrated that simultaneous treatment with two stentrievers (STs) as rescue treatment is very effective, with high recanalization rates even in this group of patients where other revascularization techniques have failed. There has been no observed increase in hemorrhagic complications. Recently, a prospective study has been published where treatment with two ST has been shown to be effective and safe if used as a first-choice treatment (not as rescue) with a successful recanalization rate (eTICI 2c/3) after the first pass of 69%. These results have been reinforced after the publication of a randomized study that confirms, in vitro, the superiority of using two ST over one.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Alfried Krupp Hospital Ruettenscheid
RECRUITING
Essen
Spain
Hospital Universitario de Cruces
RECRUITING
Barakaldo
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Contact Information
Primary
PEDRO VEGA VALDES, MD, PhD
peveval@yahoo.es
0034985108000
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 200
Treatments
Experimental: Double stentriever technique
Patients treated with thrombectomy with a proximal balloon guiding catheter using two stentrievers simultaneously (one of 6 mm x 50 mm and another of 6 mm x 50 mm or 4 mm x 35 mm)
Active_comparator: Single stentriever technique
Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm).
Related Therapeutic Areas
Sponsors
Leads: Fundación EPIC

This content was sourced from clinicaltrials.gov