Thrombectomy Clinical Trials

Clinical trials related to Thrombectomy Procedure

Delay Avoiding Primary Evaluation for Thrombectomy for Acute Stroke Patients With Large Vessel Occlusion in the Angiography Suite (DIRECT) Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
Michigan
Henry Ford Health System
RECRUITING
Detroit
University of Michigan Health-West
RECRUITING
Wyoming
New Jersey
HMH Hackensack University Medical Center
RECRUITING
Hackensack
New York
The Research Foundation for SUNY on behalf of University at Buffalo
RECRUITING
New York
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Santiago Ortega, MD
santy-ortega@uiowa.edu
319-384-5628
Backup
Carlos A Contreras Mesa, MSc
carlos-contrerasmesa@uiowa.edu
3194992748
Time Frame
Start Date: 2026-01-27
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 2039
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Santiago Ortega Gutierrez
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov