DTAS Workflow vs Standard Triage for Stroke Treatment

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen by Marc Ribo

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Philips Healthcare

Must not be taking: Oral anticoagulants

Disqualifiers: Coma, Seizures, Terminal illness, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The WE-TRUST study is a multi-center randomized clinical trial to assess the impact of a Direct to Angio Suite (DTAS) workflow on stroke patient outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on oral anticoagulant therapy with an INR greater than 3.0, you may be excluded from participating.

What data supports the effectiveness of the treatment Direct to Angio Suite (DTAS) for stroke?

Research shows that the Direct to Angio Suite (DTAS) approach for stroke treatment can significantly reduce the time to reperfusion, which is crucial for improving patient outcomes. Studies indicate that faster treatment times are associated with better recovery and reduced disability in stroke patients. ^{1 2 3 4 5}

Is the Direct to Angio Suite (DTAS) approach generally safe for humans?

The Direct to Angio Suite (DTAS) approach has been studied in stroke patients, and while it aims to improve treatment times, some patients showed intracerebral hemorrhage (bleeding in the brain) on imaging. This suggests that while the approach is generally used to improve outcomes, there are potential safety concerns that need to be considered. ^{2 3 4 6 7}

How is the DTAS Workflow treatment for stroke different from other treatments?

The DTAS Workflow treatment for stroke is unique because it involves taking patients directly to the angio suite for immediate imaging and potential treatment, using Philips' CBCT (Cone Beam Computed Tomography) technology, which can speed up the process compared to standard triage methods that may involve multiple steps and delays. ^{8 9 10 11 12}

Research Team

Raul G Nogueira

Principal Investigator

UPMC Stroke Institute, Pittsburgh

Marc Ribo

Principal Investigator

Vall d'Hebron University Hospital, Barcelona

Eligibility Criteria

The WE-TRUST trial is for adults who've had a stroke, can give consent, and have no major disability from past strokes. They must arrive at the hospital within 6 hours of their stroke starting and have a certain severity score on a neurological scale. People with in-hospital strokes, severe conditions or high blood pressure not suitable for thrombolysis, pregnant women, Philips employees and their families are excluded.

Inclusion Criteria

Your initial NIHSS score before joining the study needs to be 10 points or more.

I suspect I'm having a stroke and can get to a stroke center within 6 hours from when my symptoms started.

I was independent in daily activities before my stroke.

Exclusion Criteria

My doctor expects I have less than one year to live due to my illness.

I do not have bleeding disorders or take blood thinners with INR over 3.0.

You have had a severe allergic reaction to contrast dye in the past.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Direct to Angio Suite (DTAS) workflow for stroke treatment, utilizing Cone-Beam CT (CBCT) for triage and immediate intervention

Peri-procedural time

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcome measures assessed at 90 ± 14 days

90 ± 14 days

1 visit (in-person) or video call

Safety Monitoring

Monitoring for adverse events and device deficiencies from enrollment until hospital discharge

Up to 5 days

Treatment Details

Interventions

• Conventional CT/MR triage (Procedure)
• Direct to Angio Suite (DTAS) Philips' CBCT triage (Device)

Trial Overview This study compares two ways to decide treatment for stroke patients: one group goes straight to an imaging suite that uses special CBCT technology (DTAS), while the other follows traditional CT/MR scans. The goal is to see which method leads to better outcomes after the stroke.

Participant Groups

Group I: Direct tot Angiography Suite (DTAS) triage workflow Experimental Treatment 1 Intervention

Group II: Conventional CT/MR triage workflow Active Control 1 Intervention

Who Is Running the Clinical Trial?

Philips Healthcare

Lead Sponsor

Trials

127

Recruited

200,000+

Roy Jakobs

Philips Healthcare

Chief Executive Officer since 2022

Master's in Business Administration from Radboud University Nijmegen and Università degli Studi di Bologna

Dr. Roy Jakobs

Philips Healthcare

Chief Medical Officer

MD from McGill University

Philips Clinical & Medical Affairs Global

Lead Sponsor

Trials

61

Recruited

17,600+

Roy Jakobs

Philips Clinical & Medical Affairs Global

Chief Executive Officer since 2022

MBA from Erasmus University Rotterdam

Carla Goulart Peron

Philips Clinical & Medical Affairs Global

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

Rapid reperfusion therapy, such as intravenous thrombolytics and endovascular thrombectomy, significantly improves outcomes in acute ischemic stroke, with every minute saved potentially preserving up to 27 million neurons.

The emerging 'direct to angio' approach aims to streamline patient triage and treatment, potentially reducing the time to reperfusion therapy, though its safety, efficacy, and feasibility are still under review.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Transfer to the Neuroangiography Suite for Patients With Stroke. Desai, SM., Psychogios, M., Khatri, P., et al.[2023]

In a randomized controlled trial involving 60 patients, transferring stroke patients directly to the angio-suite for imaging (DTAS) significantly reduced the time from imaging to groin puncture compared to traditional CT scanner suite imaging (CTT), with a median time of 19 minutes versus 26 minutes.

However, while DTAS improved the speed of imaging to groin puncture, it resulted in a longer time from hospital admission to imaging, and ultimately did not lead to a faster overall time to final angiographic reperfusion compared to CTT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: A Randomized Trial. Pfaff, JAR., Schönenberger, S., Herweh, C., et al.[2021]

Direct transfer to the angio-suite (DTAS) for patients with suspected large vessel occlusion stroke significantly reduced workflow times, with median door-to-groin times of 16 minutes compared to 70 minutes for controls.

Patients in the DTAS group showed better clinical outcomes, including a lower NIHSS score at 24 hours and a higher rate of favorable outcomes at 90 days, with an odds ratio of 2.5 for achieving a favorable outcome compared to controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Transfer to Angio-Suite to Reduce Workflow Times and Increase Favorable Clinical Outcome. Mendez, B., Requena, M., Aires, A., et al.[2019]

The direct to angiosuite (DTAS) strategy significantly improves functional outcomes for large vessel occlusion (LVO) stroke patients, with 47.3% achieving good outcomes at 90 days compared to 34.9% with standard workflow (SW).

DTAS also reduces critical workflow times, with an average decrease of 35.09 minutes in door-to-puncture and 32.88 minutes in door-to-reperfusion, while maintaining safety, as there were no significant differences in rates of symptomatic intracranial hemorrhage or mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct to angiosuite strategy versus standard workflow triage for endovascular therapy: systematic review and meta-analysis. Galecio-Castillo, M., Vivanco-Suarez, J., Zevallos, CB., et al.[2023]

Recent advancements in computed tomography angiography (CTA) and computed tomography perfusion have made these techniques essential for quickly evaluating acute stroke patients and determining their eligibility for reperfusion therapies.

The article outlines specific protocols for contrast injection and image acquisition, emphasizing the importance of immediate analysis at the scanner to facilitate rapid treatment decisions, which is crucial in high-volume clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography angiography and computed tomography perfusion in ischemic stroke: A step-by-step approach to image acquisition and three-dimensional postprocessing. Pomerantz, SR., Harris, GJ., Desai, HJ., et al.[2019]

The novel TIA triage system implemented in the emergency department successfully reduced hospitalization rates to 30% while effectively managing patients, with 157 out of 224 patients discharged to outpatient care.

The overall stroke rate for patients managed with this triage approach was only 0.9%, significantly lower than what was predicted based on their ABCD2 scores, indicating its efficacy in preventing recurrent strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two aces: transient ischemic attack work-up as outpatient assessment of clinical evaluation and safety. Olivot, JM., Wolford, C., Castle, J., et al.[2016]

The direct-to-angiography suite (DTAS) pathway for suspected stroke patients showed a modest reduction in door-to-reperfusion times, saving between 0.2 to 3.5 minutes compared to the conventional CT pathway, based on a simulation model using two years of observational data.

However, the effectiveness of the DTAS pathway is highly sensitive to the baseline utilization of angiography suites, indicating that even a small increase in usage could negate the time savings, suggesting that further research is needed to evaluate its clinical implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of direct-to-angiography suite (DTAS) and conventional clinical pathways in stroke care: a simulation study. Bastani, M., White, TG., Martinez, G., et al.[2023]

The 3M-TAVR trial demonstrated that a minimalist approach to transcatheter aortic valve replacement (TAVR) allows for next-day hospital discharge without compromising safety, as there were no differences in death, stroke, or rehospitalization rates compared to conventional TAVR.

Patients undergoing minimalist TAVR experienced significant cost savings, with cumulative 30-day costs being $11,305 lower than those undergoing conventional TAVR, primarily due to reduced procedure duration and hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study. Butala, NM., Wood, DA., Li, H., et al.[2023]

Patients aged 50 and older undergoing surgical aortic valve replacement (SAVR) at TAVR centers had significantly lower odds of inpatient mortality (odds ratio 0.67) compared to those at non-TAVR centers, indicating better outcomes at TAVR facilities.

SAVR patients at high-volume TAVR centers experienced the lowest inpatient mortality rates (odds ratio 0.43), suggesting that the experience and resources available at these centers may enhance patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in Inpatient Outcomes After Surgical Aortic Valve Replacement at Transcatheter Aortic Valve Replacement (TAVR) and Non-TAVR Centers. Jack, G., Arora, S., Strassle, PD., et al.[2021]

Transcatheter aortic valve replacement (TAVR) is a safe and effective alternative to open heart surgery for high-risk patients, showing favorable clinical outcomes and prolonged survival.

To manage the increasing complexity of TAVR cases, St. Paul's Hospital implemented a centralized referral and triage program, along with a dedicated THV Nurse Coordinator, to enhance patient assessment, education, and continuity of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of processes of care to support transcatheter aortic valve replacement programs. Lauck, S., Achtem, L., Boone, RH., et al.[2016]

In a study of 6,231 patients undergoing transcatheter aortic valve replacement (TAVR) in Michigan, hospitals designated as comprehensive stroke centers (CSC) had significantly higher in-hospital stroke rates (2.65%) compared to non-CSC hospitals (1.15%).

Despite the higher stroke rates at CSC hospitals, there was no significant difference in other important clinical outcomes, such as 30-day mortality, suggesting that CSC designation may influence stroke detection but not overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Hospital Stroke Center Designation and TVT Reported Stroke: The Michigan TAVR Experience. Grossman, PM., Sukul, D., Lall, SC., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Direct Transfer to the Neuroangiography Suite for Patients With Stroke. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Direct Transfer to Angio-Suite Versus Computed Tomography-Transit in Patients Receiving Mechanical Thrombectomy: A Randomized Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Direct Transfer to Angio-Suite to Reduce Workflow Times and Increase Favorable Clinical Outcome. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Direct to angiosuite strategy versus standard workflow triage for endovascular therapy: systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Computed tomography angiography and computed tomography perfusion in ischemic stroke: A step-by-step approach to image acquisition and three-dimensional postprocessing. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Two aces: transient ischemic attack work-up as outpatient assessment of clinical evaluation and safety. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of direct-to-angiography suite (DTAS) and conventional clinical pathways in stroke care: a simulation study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Practical considerations for optimizing cardiac computed tomography protocols for comprehensive acquisition prior to transcatheter aortic valve replacement. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Differences in Inpatient Outcomes After Surgical Aortic Valve Replacement at Transcatheter Aortic Valve Replacement (TAVR) and Non-TAVR Centers. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Implementation of processes of care to support transcatheter aortic valve replacement programs. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

The Relationship Between Hospital Stroke Center Designation and TVT Reported Stroke: The Michigan TAVR Experience. [2023]