Stroke, AcuteANGIOCATNCT04001738
Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial (ANGIOCAT)
A study testing Direct Transfer to Angio Suite in people with Stroke, Acute, run by Hospital Vall d'Hebron at 1 site in Spain.
Trial summary
To evaluate the hypothesis that an ultra-fast triage with one-stop in angiography suite based on cone-beam CT compared to traditional protocol offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with suspected large vessel occlusion (LVO) within… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Direct Transfer to Angio Suite
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSpain
- Study dates
- 14 Aug 2018to 7 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Large vessel occlusion suspected acute stroke codes (RACE>4) within 6 hours from stroke onset which are prenotified from emergency medical system.
- Confirmed NIHSS>10 at arrival.
- Good pre-stroke functional status (mRS≤2)
- Angiography suite available.
- Endovascular treatment team available (Neurologist, Interventionist, anesthesiologist, Nursery, Technicians…)
Who cannot join
- Hemodynamically unstable patients who requires of advanced vital support.
- Patients with an advanced disease that conditions a life expectancy lower than 6 months.
- Participation in other clinical trial with a drug or device which could influence in the outcome.
- Patients with neurological or psychiatric disease that could confound future evaluations.
- Lack of disponibility for 90 days tracing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial
To evaluate the hypothesis that an ultra-fast triage with one-stop in angiography suite based on cone-beam CT compared to traditional protocol offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with suspected large vessel occlusion (LVO) within 6 hours from symptoms onset.
Read the detailed description
Prospective, randomized, open, treatment-blinded trial of acute stroke patients with suspected large vessel occlusion within 6 hours from symptoms onset in which two strategies will be compared: Direct Transfer to Angiography Suite (DTAS) vs. Computed Tomography Suite (DTCT). The study will be unicentric however there is the possibility of incorporating new stroke centers with previous experience of at least 50 DTAS cases.
The RACE scale (Rapid Arterial oCclusion Evaluation) will be used as a prehospital screening tool to identify acute stroke patients with suspicion of LVO. Once prenotifying the imminent arrival and the verified inclusion and exclusion criteria by the Neurologist at arrival, the patient will be randomized by an app in one of both study protocols.
Subjects will be followed up to 90 days post-randomization.
- Conditions
- Stroke, Acute
- Being tested
- Direct Transfer to Angio Suite
- Keywords
- Endovascular treatment, Large Vessel Occlusion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Transfer to Angio SuiteOther
Patient will be direct transferred to angiography suite where EVT team will be waiting for it.
| Study group | Role | What they receive |
|---|---|---|
| Direct Transfer to Angio Suite | Active comparator | After a fast neurological evaluation, patient will be direct transferred to angiography suite where endovascular treatment (EVT) team will be waiting for it. It will be done a cone beam-CT and if the image don't contraindicate endovascular treatment it will be performed and the large vessel occlusion will be confirmed by arteriography. If intravenous treatment have not been previously administered, it will be able to start in parallel. Receives: Other: Direct Transfer to Angio Suite |
| Direct Transfer to CT Scan | No intervention | After a fast neurological evaluation, patient will be transferred to CT suite where usual image protocol will be performed (CT and CT-angio). Within 6 hours from onset CT perfusion could be required to take detections. Once interpreted image results, it will be decided intravenous and/or endovascular treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome measurde by modified Rankin Scale score (shift analysis)
Modified Rankin Scale score in ischemic stroke patients with large vessel occlusion as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment.
Modified Rankin Scale measures functional status with a range from 0 (asymptomatic) to 6 (dead).
Measured: 90 days
Rate of patients with treatment associated complications.
Lack of treatment associated complications, mainly hemorrhagic transformation.
Measured: 72 hours
Secondary outcomes (4)
Delay of inhospital times
Time from door to groin puncture
Measured: 8 hours
Rate of dramatic improvement
10 NIHSS points drop or NIHSS <2
Measured: 24 hours
Rate of good functional outcome
Modified Rankin Scale score ≤2
Measured: 90 days
Rate of patients treated by endovascular treatment
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start14 Aug 2018
- Primary completion7 Nov 2020
- Study completion7 Nov 2020
Why it stopped: Intermediate analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Requena Ruiz, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001738
- Sponsor's protocol ID
- PR(AG)156/2018
- Acronym
- ANGIOCAT
- Status last verified
- Dec 2020
- First submitted
- 26 Jun 2019
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perez de la Ossa N, Carrera D, Gorchs M, Querol M, Millan M, Gomis M, Dorado L, Lopez-Cancio E, Hernandez-Perez M, Chicharro V, Escalada X, Jimenez X, Davalos A. Design and validation of a prehospital stroke scale to predict large arterial occlusion: the rapid arterial occlusion evaluation scale. Stroke. 2014 Jan;45(1):87-91. doi: 10.1161/STROKEAHA.113.003071. Epub 2013 Nov 26.
PubMed 24281224Ribo M, Boned S, Rubiera M, Tomasello A, Coscojuela P, Hernandez D, Pagola J, Juega J, Rodriguez N, Muchada M, Rodriguez-Luna D, Molina CA. Direct transfer to angiosuite to reduce door-to-puncture time in thrombectomy for acute stroke. J Neurointerv Surg. 2018 Mar;10(3):221-224. doi: 10.1136/neurintsurg-2017-013038. Epub 2017 Apr 26.
PubMed 28446535Jadhav AP, Kenmuir CL, Aghaebrahim A, Limaye K, Wechsler LR, Hammer MD, Starr MT, Molyneaux BJ, Rocha M, Guyette FX, Martin-Gill C, Ducruet AF, Gross BA, Jankowitz BT, Jovin TG. Interfacility Transfer Directly to the Neuroangiography Suite in Acute Ischemic Stroke Patients Undergoing Thrombectomy. Stroke. 2017 Jul;48(7):1884-1889. doi: 10.1161/STROKEAHA.117.016946. Epub 2017 May 23.
PubMed 28536177Psychogios MN, Behme D, Schregel K, Tsogkas I, Maier IL, Leyhe JR, Zapf A, Tran J, Bahr M, Liman J, Knauth M. One-Stop Management of Acute Stroke Patients: Minimizing Door-to-Reperfusion Times. Stroke. 2017 Nov;48(11):3152-3155. doi: 10.1161/STROKEAHA.117.018077. Epub 2017 Oct 10.
PubMed 29018132Mendez B, Requena M, Aires A, Martins N, Boned S, Rubiera M, Tomasello A, Coscojuela P, Muchada M, Rodriguez-Luna D, Rodriguez-Villatoro N, Juega J, Pagola J, Molina CA, Ribo M. Direct Transfer to Angio-Suite to Reduce Workflow Times and Increase Favorable Clinical Outcome. Stroke. 2018 Nov;49(11):2723-2727. doi: 10.1161/STROKEAHA.118.021989.
PubMed 30355182Requena M, Olive-Gadea M, Muchada M, Hernandez D, Rubiera M, Boned S, Pinana C, Deck M, Garcia-Tornel A, Diaz-Silva H, Rodriguez-Villatoro N, Juega J, Rodriguez-Luna D, Pagola J, Molina C, Tomasello A, Ribo M. Direct to Angiography Suite Without Stopping for Computed Tomography Imaging for Patients With Acute Stroke: A Randomized Clinical Trial. JAMA Neurol. 2021 Sep 1;78(9):1099-1107. doi: 10.1001/jamaneurol.2021.2385.
PubMed 34338742
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04001738
- Acronym / sponsor ID
- ANGIOCAT / PR(AG)156/2018
- Conditions
- Stroke, Acute
- Keywords
- Endovascular treatment, Large Vessel Occlusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intermediate analysis
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 7 Nov 2020 (actual)
- Study completion
- 7 Nov 2020 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the hypothesis that an ultra-fast triage with one-stop in angiography suite based on cone-beam CT compared to traditional protocol offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with suspected large vessel occlusion (LVO) within 6 hours from symptoms onset.
Detailed description
Prospective, randomized, open, treatment-blinded trial of acute stroke patients with suspected large vessel occlusion within 6 hours from symptoms onset in which two strategies will be compared: Direct Transfer to Angiography Suite (DTAS) vs. Computed Tomography Suite (DTCT). The study will be unicentric however there is the possibility of incorporating new stroke centers with previous experience of at least 50 DTAS cases.
The RACE scale (Rapid Arterial oCclusion Evaluation) will be used as a prehospital screening tool to identify acute stroke patients with suspicion of LVO. Once prenotifying the imminent arrival and the verified inclusion and exclusion criteria by the Neurologist at arrival, the patient will be randomized by an app in one of both study protocols.
Subjects will be followed up to 90 days post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Transfer to Angio Suite | Active comparator | Other: Direct Transfer to Angio SuiteAfter a fast neurological evaluation, patient will be direct transferred to angiography suite where endovascular treatment (EVT) team will be waiting for it. It will be done a cone beam-CT and if the image don't contraindicate endovascular treatment it will be performed and the large vessel occlusion will be confirmed by arteriography. If intravenous treatment have not been previously administered, it will be able to start in parallel. |
| Direct Transfer to CT Scan | No intervention | –After a fast neurological evaluation, patient will be transferred to CT suite where usual image protocol will be performed (CT and CT-angio). Within 6 hours from onset CT perfusion could be required to take detections. Once interpreted image results, it will be decided intravenous and/or endovascular treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Large vessel occlusion suspected acute stroke codes (RACE>4) within 6 hours from stroke onset which are prenotified from emergency medical system.
- Confirmed NIHSS>10 at arrival.
- Good pre-stroke functional status (mRS≤2)
- Angiography suite available.
- Endovascular treatment team available (Neurologist, Interventionist, anesthesiologist, Nursery, Technicians…)
Key exclusion criteria (5 listed)
- Hemodynamically unstable patients who requires of advanced vital support.
- Patients with an advanced disease that conditions a life expectancy lower than 6 months.
- Participation in other clinical trial with a drug or device which could influence in the outcome.
- Patients with neurological or psychiatric disease that could confound future evaluations.
- Lack of disponibility for 90 days tracing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Transfer to Angio SuitePatient will be direct transferred to angiography suite where EVT team will be waiting for it. | Other | Direct Transfer to Angio Suite |
Primary outcome
Clinical outcome measurde by modified Rankin Scale score (shift analysis)
Time frame: 90 days
Modified Rankin Scale score in ischemic stroke patients with large vessel occlusion as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment. Modified Rankin Scale measures functional status with a range from 0 (asymptomatic) to 6 (dead).
Rate of patients with treatment associated complications.
Time frame: 72 hours
Lack of treatment associated complications, mainly hemorrhagic transformation.
4 secondary outcomes
Delay of inhospital times
Time frame: 8 hours
Rate of dramatic improvement
Time frame: 24 hours
Rate of good functional outcome
Time frame: 90 days
Rate of patients treated by endovascular treatment
Time frame: 8 hours
Results and safety
The study was stopped early (reason given: Intermediate analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 24281224Perez de la Ossa N, Carrera D, Gorchs M, Querol M, Millan M, Gomis M, Dorado L, Lopez-Cancio E, Hernandez-Perez M, Chicharro V, Escalada X, Jimenez X, Davalos A. Design and validation of a prehospital stroke scale to predict large arterial occlusion: the rapid arterial occlusion evaluation scale. Stroke. 2014 Jan;45(1):87-91. doi: 10.1161/STROKEAHA.113.003071. Epub 2013 Nov 26.
- Background: PubMed 28446535Ribo M, Boned S, Rubiera M, Tomasello A, Coscojuela P, Hernandez D, Pagola J, Juega J, Rodriguez N, Muchada M, Rodriguez-Luna D, Molina CA. Direct transfer to angiosuite to reduce door-to-puncture time in thrombectomy for acute stroke. J Neurointerv Surg. 2018 Mar;10(3):221-224. doi: 10.1136/neurintsurg-2017-013038. Epub 2017 Apr 26.
- Background: PubMed 28536177Jadhav AP, Kenmuir CL, Aghaebrahim A, Limaye K, Wechsler LR, Hammer MD, Starr MT, Molyneaux BJ, Rocha M, Guyette FX, Martin-Gill C, Ducruet AF, Gross BA, Jankowitz BT, Jovin TG. Interfacility Transfer Directly to the Neuroangiography Suite in Acute Ischemic Stroke Patients Undergoing Thrombectomy. Stroke. 2017 Jul;48(7):1884-1889. doi: 10.1161/STROKEAHA.117.016946. Epub 2017 May 23.
- Background: PubMed 29018132Psychogios MN, Behme D, Schregel K, Tsogkas I, Maier IL, Leyhe JR, Zapf A, Tran J, Bahr M, Liman J, Knauth M. One-Stop Management of Acute Stroke Patients: Minimizing Door-to-Reperfusion Times. Stroke. 2017 Nov;48(11):3152-3155. doi: 10.1161/STROKEAHA.117.018077. Epub 2017 Oct 10.
- Background: PubMed 30355182Mendez B, Requena M, Aires A, Martins N, Boned S, Rubiera M, Tomasello A, Coscojuela P, Muchada M, Rodriguez-Luna D, Rodriguez-Villatoro N, Juega J, Pagola J, Molina CA, Ribo M. Direct Transfer to Angio-Suite to Reduce Workflow Times and Increase Favorable Clinical Outcome. Stroke. 2018 Nov;49(11):2723-2727. doi: 10.1161/STROKEAHA.118.021989.
- Derived from this study: PubMed 34338742Requena M, Olive-Gadea M, Muchada M, Hernandez D, Rubiera M, Boned S, Pinana C, Deck M, Garcia-Tornel A, Diaz-Silva H, Rodriguez-Villatoro N, Juega J, Rodriguez-Luna D, Pagola J, Molina C, Tomasello A, Ribo M. Direct to Angiography Suite Without Stopping for Computed Tomography Imaging for Patients With Acute Stroke: A Randomized Clinical Trial. JAMA Neurol. 2021 Sep 1;78(9):1099-1107. doi: 10.1001/jamaneurol.2021.2385.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Transfer to Angio Suite in people with Stroke, Acute, run by Hospital Vall d'Hebron at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Intermediate analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome measurde by modified Rankin Scale score (shift analysis) (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001738, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.