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New treatment option for Stroke, Acute
Official title Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
ClinicalTrials.gov ID: NCT06825897
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Hemorrhagic Stroke: Presence of intracranial hemorrhage on brain imaging in the conventional strategy as Heidelberg that renders thrombectomy...
See the full eligibility criteria
- 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...
- 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...
- 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...
- Hemorrhagic Stroke: Presence of intracranial hemorrhage on brain imaging in the conventional strategy as Heidelberg that renders thrombectomy contraindicated.
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- Detroit, Michigan, United States
- Wyoming, Michigan, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; Detroit, Michigan, United States; Wyoming, Michigan, United States; Hackensack, New Jersey, United States; New York, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.