Randomized a Clinical Trial With Medical Device in Acute Ischemic Stroke

NCT07113184 | Not Yet Recruiting DMC

• 1 other identifier: DOBLE UP
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke; mechanical thrombectomy; dual stentriever; mTICI; first pass effect; randomized trial

Outcome Measures

Primary Outcomes (1)

• Time takes in achieving complete reperfusion after a single thrombectomy pass.

  To evaluate the superiority of the dual stentriever technique in achieving complete reperfusion after a single thrombectomy pass.

  24 hours or 48 hours after thrombectomy

Study Arms (2)

Dual Stentriever

EXPERIMENTAL

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

Device: dual sr

Single Stentriever

ACTIVE COMPARATOR

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

Device: single sr

Interventions

dual sr DEVICE

Dual Stentriever

Also known as: experimental

Dual Stentriever

single sr DEVICE

Single Stentriever

Also known as: control

Single Stentriever

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (3)

Hospital de Burgos

Burgos, Spain

Location

Complejo Hospitalario de Salamanca

Salamanca, Spain

Location

Hospital universitario marques de valdecilla

Santander, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Endovascular mechanical thrombectomy with either dual or single stentriever technique using a balloon guiding catheter.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)