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 — OTHERParticipants 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 — OTHERPatients 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 ArmIn 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) ArmDescription: 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
- Santiago Ortega, MD319-384-5628
- Carlos A Contreras Mesa, MSc3194992748
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | Santiago Ortega, MD |
| Henry Ford Health System | Detroit | Michigan | 48202 | Alex Chebl, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan Health-West | Wyoming | Michigan | 49519 | Fazeel Siddiqui, MD (PRINCIPAL_INVESTIGATOR) |
| HMH Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Haralabos Zacharatos, MD (PRINCIPAL_INVESTIGATOR) |
| The Research Foundation for SUNY on behalf of University at Buffalo | New York | New York | 14203 | Adnan Siddiqui, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Alexandra Czap, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Iowa City, IA
By research site
University of Iowa· Iowa City, IAHenry Ford Health System· Detroit, MIUniversity of Michigan Health-West· Wyoming, MIHMH Hackensack University Medical Center· Hackensack, NJThe Research Foundation for SUNY on behalf of University at Buffalo· New York, NYThe University of Texas Health Science Center at Houston· Houston, TX
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