Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Santiago Ortega Gutierrez
Study ID
NCT06825897
Status
Recruiting

Conditions

  • Stroke, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional Triage for Mechanical Thrombectomy — OTHER
    Participants undergo the conventional standard-of-care triage process. Upon arrival at the thrombectomy-capable center, patients first undergo an initial evaluation in the emergency department (ED), which includes diagnostic imaging (CT or MRI) to confirm eligibility for mechanical thrombectomy (MT). If the patient is found to have a large vessel occlusion (LVO) suitable for thrombectomy, they are transferred to the neurointerventional suite for treatment.
  • Direct Transfer to Angiography Suite (DTAS — OTHER
    Patients who arrive at the thrombectomy-capable center (from home, mobile stroke units, or interfacility transfer) are immediately transferred to the neurointerventional suite, bypassing the emergency department (ED). Upon arrival in the neurointerventional suite, initial neuroimaging (typically using flat panel CT or other imaging modalities) is conducted to confirm the presence of a large vessel occlusion (LVO). If the patient is eligible for mechanical thrombectomy (MT), treatment is initiated directly in the angiography suite. This approach aims to reduce delays in care and improve clinical outcomes by providing faster access to thrombectomy treatment.

Study Details

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.

Key Dates

Start date
Jan 27, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
2,039 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional Triage Arm
    In this arm, patients with suspected large vessel occlusion (LVO) stroke undergo an initial evaluation in the emergency department (ED), including standard imaging, to confirm eligibility for mechanical thrombectomy (MT). Once eligibility is confirmed, they are transferred to the neurointerventional suite for further treatment. This strategy represents the traditional approach used in many stroke centers and serves as a comparator to the direct transfer strategy. The outcomes measured in this arm will be compared to those in the Direct Transfer to Angiography Suite (DTAS) arm to assess the relative effectiveness and safety of both triage strategies.
  • Active Comparator: Direct Transfer to Angiography Suite (DTAS) Arm
    Description: In this arm, patients with suspected large vessel occlusion (LVO) stroke are directly transferred to the neurointerventional angiography suite without initial evaluation in the emergency department. Neuroimaging is performed using flat panel CT (FPCT) to confirm treatment eligibility for mechanical thrombectomy (MT). This strategy aims to reduce delays in treatment and improve clinical outcomes by bypassing the emergency department, leading to faster access to thrombectomy. This arm will assess the effectiveness and safety of direct transfer, comparing it to the conventional triage strategy in terms of disability outcomes, safety, and healthcare utilization.

Primary Outcome Measure

Global Disability at 90 Days [ Time Frame: 90 days (±14 days) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Santiago Ortega, MD
Henry Ford Health SystemDetroitMichigan48202
Nicolette Bicknell
313-916-1756
Alex Chebl, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Health-WestWyomingMichigan49519
Joan Westendorp
616-252-4793
Fazeel Siddiqui, MD (PRINCIPAL_INVESTIGATOR)
HMH Hackensack University Medical CenterHackensackNew Jersey07601
Alexandra Burbelo
732-321-7000
Haralabos Zacharatos, MD (PRINCIPAL_INVESTIGATOR)
The Research Foundation for SUNY on behalf of University at BuffaloNew YorkNew York14203
Amy Lagowski
716-645-4419
Adnan Siddiqui, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77030
Caroline Dietz
713-500-3999
Alexandra Czap, MD (PRINCIPAL_INVESTIGATOR)

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