StrokeARISEIINCT02488915
Analysis of Revascularization in Ischemic Stroke With EmboTrap
A study testing EmboTrap® Revascularization Device in people with Stroke and Ischemia, run by Neuravi Inc. at 12 sites in 4 countries.
Trial summary
The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- EmboTrap® Revascularization Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Nov 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
- Aged between 18 years and 85 years (inclusive).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- NIHSS score ≥8 and ≤25.
- Pre-ictal mRS score of 0 or 1.
- The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms.
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- Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA.
- IV-tPA, if used, was initiated within 3 hrs of stroke onset (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight.
- Angiographic confirmation of an occlusion of an ICA (including T or L occlusions), M1 or M2 MCA, VA, or BA with mTICI flow of 0 - 1.
- For strokes in the anterior circulation the following imaging criteria should also be met:
- MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR
- CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤50 mL.
- The patient is indicated for neurothrombectomy treatment by the interventionalist and it is confirmed by diagnostic angiography that the device will be able to reach the target lesion proximally.
Who cannot join
- Life expectancy likely less than 6 months.
- Females who are pregnant or breastfeeding.
- History of severe allergy to contrast medium.
- Known nickel allergy at time of treatment.
- Known current use of cocaine at time of treatment.
- Patient has suffered a stroke in the past 3 months.
Show all 27Show fewer
- The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
- Subject participating in another study involving an investigational device or drug.
- Use of warfarin anticoagulation or any Novel Anticoagulant with International Normalized Ratio (INR) >3.0.
- Platelet count <50,000/μL.
- Glucose <50 mg/dL.
- Any known hemorrhagic or coagulation deficiency.
- Unstable renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
- Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible.
- All patients with severe hypertension on presentation (SBP> 220mmHg and/or DBP>120mmHg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous therapy (SBP >185mmHg and/or DBP>110mmHg). .
- Known cerebral vasculitis.
- Rapidly improving neurological status.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Ongoing seizure due to stroke.
- Evidence of active systemic infection.
- Known cancer with metastases.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
- Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
- Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
- Evidence of dissection in the extra or intracranial cerebral arteries.
- Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States9 sites
Emory University School of Medicine,
Atlanta, Georgia, 30303
Tennessee Interventional and Imaging Associates
Chattanooga, Tennessee, 37403
Riverside Radiology and Interventional Associates
Columbus, Ohio, 43214
UCLA
Los Angeles, California, 90095
University of Miami and Jackson Memorial Hospital
Miami, Florida, 33136
UPMC Stroke Center
Pittsburgh, Pennsylvania, 15213
OHSU Stroke Center
Portland, Oregon, 97239
Good Samaritan Hospital and Regional Medical Center
San Jose, California, 95124
St Vincent Mercy Hospital
Toledo, Ohio, 43608
About this study
Official title: ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) Study
The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.
- Being tested
- EmboTrap® Revascularization Device
- Keywords
- Brain, Brain Clot, Brain Diseases, Brain Infarction, Cerebral Ischemia, Cerebrovascular Disorders, EmboTrap® Revascularization Device, EmboTrap, Ischemia, Ischemic, Ischemic Stroke, Mechanical Thrombectomy, Neurovascular Intervention, Revascularization, Stent Retriever, Stroke, Vascular Diseases, Neuravi
- Medical subject headings
- Stroke, Ischemia, Brain Diseases, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Ischemic Stroke, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmboTrap® Revascularization DeviceDevice
Also called EmboTrap II
| Study group | Role | What they receive |
|---|---|---|
| EmboTrap® Revascularization Device | Experimental | Mechanical Thrombectomy with EmboTrap Receives: Device: EmboTrap® Revascularization Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were treated as failures to meet the primary revascularization endpoint. (Post measurement of the primary endpoint some patients subsequently received additional treatment.)
-
mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:
mTICI 0 = No perfusion
mTICI 1 = Penetration but not perfusion
mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized
mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized
mTICI 2c = Near-complete perfusion
mTICI 3 = Complete perfusion
Measured: Post-treatment
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)
The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH).
sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. SADE was categorized as any serious adverse event that was deemed to be caused by the study device.
Measured: 24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure
Secondary outcomes (10)
Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2
Good Clinical Outcome is defined as achieving an mRS score of ≤2 at 90 days post procedure.
-
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6:
mRS 0 = No symptoms.
mRS 1 = No significant disability.
mRS 2 = Slight disability.
mRS 3 = Moderate disability.
mRS 4 = Moderately severe disability.
mRS 5 = Severe disability.
mRS 6 = Dead.
Measured: 90(±14) days Post Procedure
Procedure Time
The time from groin puncture to achievement of mTICI ≥2b, or if not obtained, to the final angiogram.
-
mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:
mTICI 0 = No perfusion
mTICI 1 = Penetration but not perfusion
mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized
mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized
mTICI 2c = Near-complete perfusion
mTICI 3 = Complete perfusion
Measured: Post-treatment
All Procedure-related Mortality
Any death that is deemed to have been caused by the study procedure.
Measured: Day 7 post-procedure
All-cause Mortality
Any death that occurs within 90(±14) days post-procedure.
Measured: 90(±14) days Post Procedure
Occurrence of Serious Adverse Device Effects (SADE)
SADE was categorized as any serious adverse event that was deemed to be caused by the study device.
Measured: 90(±14) days Post Procedure
Occurrence of Procedure Related Serious Adverse Events (PRSAE)
PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure.
Measured: 90(±14) days Post Procedure
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)
sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention.
Measured: 24(-8/+12) hours post-procedure
Occurrence of Neurological Deterioration
An increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (-8/+12 hrs) post-procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.
Measured: 24(-8/+12) hours post-procedure
Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory
Infarction (i.e. brain tissue death) of a previously uninvolved vascular territory (i.e. region of the brain) is evaluated from 24-hour imaging (Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)).
Measured: 24(-8/+12) hours post-procedure
Time to Treat
The time from first baseline angiogram to achievement of mTICI ≥2b, or if not obtained, to the final angiogram.
-
mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:
mTICI 0 = No perfusion
mTICI 1 = Penetration but not perfusion
mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized
mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized
mTICI 2c = Near-complete perfusion
mTICI 3 = Complete perfusion
Measured: Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuravi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Sam Zaidat, M.D., Principal investigator, St. Vincent Mercy Mercy Hospital, Toledo,Ohio, USAProf. Tommy Andersson, M.D., Principal investigator, Karolinska InstitutetProf. Jeffery Saver, M.D., Study director, UCLA, CA, USA.Prof. Heinrich Mattle, M.D., Study director, University of Berne, Berne, Switzerland.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488915
- Sponsor's protocol ID
- CIP002
- Acronym
- ARISEII
- Status last verified
- Jun 2018
- First submitted
- 30 Jun 2015
- Last updated
- 13 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ashouri Y, AlMajali M, Chaudhari A, Andersson T, Saver JL, Chebl AB, Bushnaq S, Liaw N, Bozorgchami H, Ribo M, Chaubal V, Mattle HP, Chapot R, Narata AP, Francois O, Jadhav AP, Grossberg JA, Riedel CH, Tomasello A, Clark WM, Nordmeyer H, Lin E, Nogueira RG, Yoo AJ, Jovin TG, Siddiqui AH, Zaidat OO. Diving MCA and First-Pass Effect: A Subgroup Analysis From the ARISE II Study. Stroke Vasc Interv Neurol. 2026 Aug 21;6(5):e002247. doi: 10.1161/SVIN.125.002247. eCollection 2026 Sep.
PubMed 42707779Yoo AJ, Soomro J, Andersson T, Saver JL, Ribo M, Bozorgchami H, Dabus G, Liebeskind DS, Jadhav A, Mattle H, Zaidat OO. Benchmarking the Extent and Speed of Reperfusion: First Pass TICI 2c-3 Is a Preferred Endovascular Reperfusion Endpoint. Front Neurol. 2021 May 11;12:669934. doi: 10.3389/fneur.2021.669934. eCollection 2021.
PubMed 34046008Zaidat OO, Bozorgchami H, Ribo M, Saver JL, Mattle HP, Chapot R, Narata AP, Francois O, Jadhav AP, Grossberg JA, Riedel CH, Tomasello A, Clark WM, Nordmeyer H, Lin E, Nogueira RG, Yoo AJ, Jovin TG, Siddiqui AH, Bernard T, Claffey M, Andersson T. Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke. 2018 May;49(5):1107-1115. doi: 10.1161/STROKEAHA.117.020125. Epub 2018 Apr 11.
PubMed 29643261
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) Study
- ClinicalTrials.gov ID
- NCT02488915
- Acronym / sponsor ID
- ARISEII / CIP002
- Keywords
- Brain, Brain Clot, Brain Diseases, Brain Infarction, Cerebral Ischemia, Cerebrovascular Disorders, EmboTrap® Revascularization Device, EmboTrap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Neuravi Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 13 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EmboTrap® Revascularization Device | Experimental | Device: EmboTrap® Revascularization DeviceMechanical Thrombectomy with EmboTrap |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
- Aged between 18 years and 85 years (inclusive).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- NIHSS score ≥8 and ≤25.
- Pre-ictal mRS score of 0 or 1.
Key exclusion criteria (27 listed)
- Life expectancy likely less than 6 months.
- Females who are pregnant or breastfeeding.
- History of severe allergy to contrast medium.
- Known nickel allergy at time of treatment.
- Known current use of cocaine at time of treatment.
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 |
|---|---|---|
| EmboTrap® Revascularization DeviceAlso: EmboTrap II | Device | EmboTrap® Revascularization Device |
Primary outcome
Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
Time frame: Post-treatment
Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were treated as failures to meet the primary revascularization endpoint. (Post measurement of the primary endpoint some patients subsequently received additional treatment.) - mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)
Time frame: 24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure
The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH). sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. SADE was categorized as any serious adverse event that was deemed to be caused by the study device.
10 secondary outcomes
Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2
Time frame: 90(±14) days Post Procedure
Procedure Time
Time frame: Post-treatment
All Procedure-related Mortality
Time frame: Day 7 post-procedure
All-cause Mortality
Time frame: 90(±14) days Post Procedure
Occurrence of Serious Adverse Device Effects (SADE)
Time frame: 90(±14) days Post Procedure
Occurrence of Procedure Related Serious Adverse Events (PRSAE)
Time frame: 90(±14) days Post Procedure
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)
Time frame: 24(-8/+12) hours post-procedure
Occurrence of Neurological Deterioration
Time frame: 24(-8/+12) hours post-procedure
Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory
Time frame: 24(-8/+12) hours post-procedure
Time to Treat
Time frame: Post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42707779Ashouri Y, AlMajali M, Chaudhari A, Andersson T, Saver JL, Chebl AB, Bushnaq S, Liaw N, Bozorgchami H, Ribo M, Chaubal V, Mattle HP, Chapot R, Narata AP, Francois O, Jadhav AP, Grossberg JA, Riedel CH, Tomasello A, Clark WM, Nordmeyer H, Lin E, Nogueira RG, Yoo AJ, Jovin TG, Siddiqui AH, Zaidat OO. Diving MCA and First-Pass Effect: A Subgroup Analysis From the ARISE II Study. Stroke Vasc Interv Neurol. 2026 Aug 21;6(5):e002247. doi: 10.1161/SVIN.125.002247. eCollection 2026 Sep.
- Derived from this study: PubMed 34046008Yoo AJ, Soomro J, Andersson T, Saver JL, Ribo M, Bozorgchami H, Dabus G, Liebeskind DS, Jadhav A, Mattle H, Zaidat OO. Benchmarking the Extent and Speed of Reperfusion: First Pass TICI 2c-3 Is a Preferred Endovascular Reperfusion Endpoint. Front Neurol. 2021 May 11;12:669934. doi: 10.3389/fneur.2021.669934. eCollection 2021.
- Derived from this study: PubMed 29643261Zaidat OO, Bozorgchami H, Ribo M, Saver JL, Mattle HP, Chapot R, Narata AP, Francois O, Jadhav AP, Grossberg JA, Riedel CH, Tomasello A, Clark WM, Nordmeyer H, Lin E, Nogueira RG, Yoo AJ, Jovin TG, Siddiqui AH, Bernard T, Claffey M, Andersson T. Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke. 2018 May;49(5):1107-1115. doi: 10.1161/STROKEAHA.117.020125. Epub 2018 Apr 11.
- Individual participant dataSharing planned: No
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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.
Prof. Sam Zaidat, M.D. principal investigator
St. Vincent Mercy Mercy Hospital, Toledo,Ohio, USA
Prof. Tommy Andersson, M.D. principal investigator
Karolinska Institutet
Prof. Jeffery Saver, M.D. study director
UCLA, CA, USA.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmboTrap® Revascularization Device in people with Stroke and Ischemia, run by Neuravi Inc. at 12 sites in 4 countries.
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 13 inclusion and 27 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: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Belgium, Germany, Ireland. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating) (time frame: Post-treatment). 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 NCT02488915, which also lists 3 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 13 Jul 2018.