Randomized a Clinical Trial With Medical Device in Acute Ischemic Stroke (DOBLE UP)

Instituto de Investigación Marqués de Valdecilla

Status: Not yet enrolling

Conditions: Acute Ischemic Stroke

Treatments: Device: dual sr; Device: single sr

Study type: Interventional

Funder types: Other

Identifiers

NCT07113184

DOBLE UP

Details and patient eligibility

About

This study seeks to provide high-quality evidence on the potential benefits of the dual stentriever approach, potentially informing future clinical guidelines and improving outcomes in patients with anterior circulation large vessel occlusion strokes.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• NIHSS ≥ 6
• mRS ≤ 1
• Proximal anterior circulation occlusion
• ASPECTS > 6
• Informed consent

Exclusion criteria

• Absence of occlusion
• Posterior circulation stroke
• Carotid dissection or tandem stenosis requiring treatment
• Severe comorbidities or contraindications to imaging contrast

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 2 patient groups

Dual Stentriever

Experimental group

Description:

Endovascular mechanical thrombectomy with dual or stentriever technique using a balloon guiding catheter.

Treatment:

Device: dual sr

Single Stentriever

Active Comparator group

Description:

Endovascular mechanical thrombectomy with single stentriever technique using a balloon guiding catheter.

Treatment:

Device: single sr