NCT06825897Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Delay Avoiding Primary Evaluation for Thrombectomy for Acute Stroke Patients With Large Vessel Occlusion in the Angiography Suite (DIRECT) Trial
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to compare two strategies for treating adults with suspected large vessel occlusion stroke within 7 hours of symptom onset. Researchers will evaluate whether direct transfer to the neurointerventional angiography suite improves recovery and reduces disability compared to the conventional approach of first being evaluated in the emergency department. The study will also assess safety and other health outcomes to guide care for stroke patients.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2039 (estimated)
- First submitted
- 29 Jan 2025
- Start date
- 27 Jan 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Santiago Ortega Gutierrez
- Diseases
- Stroke
- NCT number
- NCT06825897
What you commit to
- Study type: Interventional
- Planned participants: 2039
- From 27 Jan 2026 to the primary completion date, 30 Apr 2028
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hemorrhagic Stroke: Presence of intracranial hemorrhage on brain imaging in the conventional strategy as Heidelberg that renders thrombectomy contraindicated.
Other
- An individual who meets any of the following criteria will be excluded from participation in the trial:
- Time Restrictions: Presentation to a thrombectomy-capable center more than 7 hours from LSW.
- Imaging Criteria for Interfacility Transfer Patients: At sites enrolling transfer patients, any patient arriving from an outside hospital with time from imaging study at the presenting hospital to arrival at the TSC not exceeding 90 minutes.
Who the study is looking for
- To be eligible for participation in the DIRECT trial, an individual must meet all of the following criteria:
- Age: ≥ 18 years of age.
- Clinical Presentation: Present to a participating TSC with signs or symptoms suggestive of acute LVO stroke.
- Stroke Severity: Baseline NIHSS of 10 or higher.
- Time since LKW: Time from LKW to arrival at the TSC must be within 7 hours.
- Additional criteria
- For all Interfacility Transfers:
- 1\. If imaging was performed at the outside facility, the time from the first imaging to arrival at the thrombectomy center must exceed 90 minutes.
- For all the Conventional Triage Arm, participants must also meet the following criteria:
- Presence of a qualifying LVO by CTA or MRA imaging; or
- For Large Core Patients: Patients with large core infarcts (CT-ASPECT score ≤ 5, DWI-ASPECT score ≤ 5, or infarct volume ≥ 70 cc) will be enrolled, irrespective of treatment decisions regarding embolectomy.
- For all DTAS Arm:
- 1\. Patients who do not have LVO occlusions in the angiography suite assessment (ICH, distal occlusions or mimics) will be enrolled, irrespective of treatment decisions regarding embolectomy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cooper University Hospital Coordinator of this site? Confirm its status | Camden | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Texas Tech University Health Sciences Center-El Paso Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| HMH-Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Valley Baptist Medical Center Coordinator of this site? Confirm its status | Harlingen | United States | Recruiting |
| Memorial Healthcare System Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Miami/ Jackson Memorial Hospital Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Rutgers New Jersey Medical School Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| The Research Foundation for SUNY on behalf of University at Buffalo Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Texas Stroke Institute Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| Saint Louis University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| ProMedica Toledo Hospital Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| University of Michigan Health - West Coordinator of this site? Confirm its status | Wyoming | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.