MedTrace Logo

Effect of DIRECT Transfer to ANGIOsuite on Functional Outcome in Severe Acute Stroke

NCT03969511 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-08

No results posted yet for this study

Summary

Rationale: Acute large-vessel strokes, requiring endovascular treatment, are currently being managed through radiology department before being transferred to the angiography room. However, patients with severe neurological deficit have demonstrated even greater benefits from recanalization as the symptom onset-to-reperfusion time is shortened to less than 1 hour. Recent pilot study have shown a benefit in reducing management delays with direct admission to the angiography room and subsequently in increasing functional independence at 3 months. Therefore, the aim is to demonstrate the superiority of the direct angio-suite transfer versus the standard management, in terms of 3-month functional independence, in patients strongly suspected of having a severe ischemic stroke related to acute large-vessel occlusion of the anterior circulation, and treated by mechanical thrombectomy ± intravenous thrombolysis.

Methods and Design: The DIRECT ANGIO trial is a (PROBE) randomized, multicenter, controlled, open-label, blinded endpoint clinical trial.

Study Outcomes: The primary outcome is the rate of patients with 3-month functional independence defined as modified Rankin Scale score ≤2 at 3 months.

Conditions

  • Acute Ischemic Stroke

Interventions

PROCEDURE

direct angio-suite admission

Upon arrival in angio-suite and after neurological examination with scoring NIHSS and mRS, and performing the blood sample, patient undergoes rotational CBCT in order to confirm ischemic stroke. Mechanical thrombectomy is the performed as well as intravenous thrombolysis when contraindications are excluded.

PROCEDURE

standard management

Arrival is in the MRI/CT-scan room or in the emergency department. Directly after neurological examination and blood sample, patient undergoes imaging and then bridging therapy when indicated.

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2023-07-25
Completion
2024-04-03

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03969511 on ClinicalTrials.gov