Aortic StenosisNCT02389894
Neuroprotection in Patients Undergoing Aortic Valve Replacement
A study testing Embol-X Embolic Protection Device and CardioGard Cannula in people with Aortic Stenosis and Brain Infarction, run by Icahn School of Medicine at Mount Sinai at 18 sites in 2 countries.
Trial summary
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Stenosis, Brain Infarction, Cerebrovascular Accident
- What is being tested?
- Embol-X Embolic Protection Device and CardioGard Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Mar 2015to Jan 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Planned and scheduled surgical aortic valve replacement via a full or minimal-access sternotomy (using central aortic perfusion cannulae) for calcific aortic stenosis with a legally marketed valve
- No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization
- Ability to provide informed consent and comply with the protocol
Who cannot join
- Contraindication to legally marketed embolic protection devices (e.g. aneurysm of the ascending aorta, aortic trauma, porcelain aorta, known sensitivity to heparin)
- History of clinical stroke within 3 months prior to randomization
- Cardiac catheterization within 3 days of the planned aortic valve replacement
- Cerebral and or aortic arch arteriography or interventions within 3 days of the planned aortic valve replacement
- Active endocarditis at time of randomization
- Anticipated inability to tolerate or contraindication for MRI (e.g., known intolerance of MRI, permanent pacemaker at baseline or expected implantation of a permanent pacemaker)
Show all 10Show fewer
- Any other concomitant aortic procedure such as root replacement
- Concomitant surgical procedures other than CABG, mitral annuloplasty, left atrial appendage (LAA) excision or exclusion, atrial septal defect (ASD) closure or patent foramen ovale (PFO) closure
- Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
- Concurrent participation in an interventional (drug or device) trial
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States14 sites
Mission Hospital
Asheville, North Carolina, 28801
Emory University
Atlanta, Georgia, 30308
University of Maryland
Baltimore, Maryland, 21201
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, 20814
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
University of Southern California
Los Angeles, California, 90033
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Baylor Research Institute
Plano, Texas, 75093
Montefiore Einstein Heart Center
The Bronx, New York, 10467
Canada4 sites
University of Alberta Hospital
Edmonton, Alberta, T6G2B7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Québec, Quebec, G1V 4G5
Toronto General Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: Neuroprotection In Patients Undergoing Aortic Valve Replacement
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
Read the detailed description
This is a multicenter randomized trial in which patients diagnosed with calcific aortic stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life Science filter and cannula or the filter as a stand alone with any cannula or 2) to the treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.
- Conditions
- Aortic Stenosis, Brain Infarction, Cerebrovascular Accident, Stroke
- Being tested
- Embol-X Embolic Protection Device, CardioGard Cannula
- Keywords
- Embolic Protection Device, Stroke, Brain Infarction, atheroma, Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis, Brain Infarction, Stroke, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embol-X Embolic Protection DeviceDevice
Also called Edwards Embol-X embolic protection device
per the manufacturer's instructions for use (IFU).
CardioGard CannulaDevice
Also called CardioGard Emboli Protection Cannula
CardioGard Cannula, per the manufacturer's instructions for use (IFU).
| Study group | Role | What they receive |
|---|---|---|
| Embol-X Embolic Protection Device | Active comparator | The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath. Receives: Device: Embol-X Embolic Protection Device |
| CardioGard Cannula | Active comparator | The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula. Receives: Device: CardioGard Cannula |
| Standard Cannula | No intervention | Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting > 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.
Measured: up to 10 days post procedure
Secondary outcomes (20)
Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury
The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.
Measured: up to 30 days
Number of Patients With Clinically Apparent Stroke at 7 Days
The number of patients who experience a clinically apparent stroke by 7 days post-op
Measured: at 7 days
Presence of Radiographic Infarcts
The proportion of patients with radiographic infarcts on day 7 (+/-3 days) MRI. Presences of radiographic infarcts were measured using diffusion-weighted 1.5 or 3T MRI scanners
Measured: up to 10 days
Total Infarct Volume
Total infarct volume measured on day 7 dwMRI.
Measured: Day 7
Decline in Overall Neurocognition
Decline in neurocognitive function at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Measured: baseline and 90 days
Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days
Decline in neurocognitive function in the verbal memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Measured: baseline and 90 days
Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days
Decline in neurocognitive function in the visual memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Measured: baseline and 90 days
Decline in Neurocognitive Function in the Executive Function Domain at 90 Day
Decline in neurocognitive function in the executive function domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Measured: baseline and 90 days
Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days
Decline in neurocognitive function in the visuospatial/constructional praxis domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Measured: baseline and 90 days
Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days
Decline in neurocognitive function in the Auditory-Verbal Simple attention domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Measured: baseline and 90 days
Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days
Decline in neurocognitive function in the Visuomotor/Information Processing Speed domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.
Measured: baseline and 90 days
Modified Rankin Scale >2 at 90 Days
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 90 days
Barthel Index <= 80
An overall score has full range from 0 to 100, with higher scores indicating greater independence.
Measured: 90 days
Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days
Measured: 7 days
Mortality by 90 Days
Incidence of all-cause mortality
Measured: up to 90 days
Length of Stay for Index Hospitalization
Measured: up to 90 days
Hospital Readmissions
Rate of hospital readmissions
Measured: up to 90 days
Quality of Life - Physical Health Composite
Quality of Life - Physical Health Composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.
Measured: at 90 days
Quality of Life - Mental Health Composite
Quality of life - Mental health composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.
Measured: at 90 days
Number of Participants With Emboli Captured
Assessed by the presence of any debris captured in filter of embolic protection device
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2017
- Study completionJan 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 Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Annetine Gelijns, Icahn School of Medicine at Mount Sinai
- Investigators
- Annetine C Gelijns, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiRichard Weisel, MD, Study chair, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389894
- Sponsor's protocol ID
- GCO 08-1078-0009
- Other IDs
- 2U01HL088942-07
- Status last verified
- Apr 2019
- First submitted
- 10 Mar 2015
- Last updated
- 29 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Messe SR, Overbey JR, Thourani VH, Moskowitz AJ, Gelijns AC, Groh MA, Mack MJ, Ailawadi G, Furie KL, Southerland AM, James ML, Moy CS, Gupta L, Voisine P, Perrault LP, Bowdish ME, Gillinov AM, O'Gara PT, Ouzounian M, Whitson BA, Mullen JC, Miller MA, Gammie JS, Pan S, Erus G, Browndyke JN; Cardiothoracic Surgical Trials Network (CTSN) Investigators. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement. J Thorac Cardiovasc Surg. 2024 Feb;167(2):624-633.e4. doi: 10.1016/j.jtcvs.2022.01.053. Epub 2022 Mar 18.
PubMed 35483981Crestanello JA. "Not in my brain": The use of embolic protection devices to prevent brain embolization during cardiovascular procedures. J Thorac Cardiovasc Surg. 2018 Dec;156(6):e205-e206. doi: 10.1016/j.jtcvs.2018.05.114. Epub 2018 Jun 23. No abstract available.
PubMed 30007783Mack MJ, Acker MA, Gelijns AC, Overbey JR, Parides MK, Browndyke JN, Groh MA, Moskowitz AJ, Jeffries NO, Ailawadi G, Thourani VH, Moquete EG, Iribarne A, Voisine P, Perrault LP, Bowdish ME, Bilello M, Davatzikos C, Mangusan RF, Winkle RA, Smith PK, Michler RE, Miller MA, O'Sullivan KL, Taddei-Peters WC, Rose EA, Weisel RD, Furie KL, Bagiella E, Moy CS, O'Gara PT, Messe SR; Cardiothoracic Surgical Trials Network (CTSN). Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):536-547. doi: 10.1001/jama.2017.9479.
PubMed 28787505
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotection In Patients Undergoing Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT02389894
- Acronym / sponsor ID
- GCO 08-1078-0009
- Conditions
- Aortic Stenosis, Brain Infarction, Cerebrovascular Accident, Stroke
- Keywords
- Embolic Protection Device, Stroke, Brain Infarction, atheroma, Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 29 Apr 2019
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 efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
Detailed description
This is a multicenter randomized trial in which patients diagnosed with calcific aortic stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life Science filter and cannula or the filter as a stand alone with any cannula or 2) to the treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Embol-X Embolic Protection Device | Active comparator | Device: Embol-X Embolic Protection DeviceThe surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath. |
| CardioGard Cannula | Active comparator | Device: CardioGard CannulaThe Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula. |
| Standard Cannula | No intervention | –Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 60 years
- Planned and scheduled surgical aortic valve replacement via a full or minimal-access sternotomy (using central aortic perfusion cannulae) for calcific aortic stenosis with a legally marketed valve
- No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization
- Ability to provide informed consent and comply with the protocol
Key exclusion criteria (10 listed)
- Contraindication to legally marketed embolic protection devices (e.g. aneurysm of the ascending aorta, aortic trauma, porcelain aorta, known sensitivity to heparin)
- History of clinical stroke within 3 months prior to randomization
- Cardiac catheterization within 3 days of the planned aortic valve replacement
- Cerebral and or aortic arch arteriography or interventions within 3 days of the planned aortic valve replacement
- Active endocarditis at time of randomization
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 |
|---|---|---|
| Embol-X Embolic Protection DeviceAlso: Edwards Embol-X embolic protection deviceper the manufacturer's instructions for use (IFU). | Device | Embol-X Embolic Protection Device |
| CardioGard CannulaAlso: CardioGard Emboli Protection CannulaCardioGard Cannula, per the manufacturer's instructions for use (IFU). | Device | CardioGard Cannula |
Primary outcome
Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
Time frame: up to 10 days post procedure
freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting > 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.
20 secondary outcomes
Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury
Time frame: up to 30 days
Number of Patients With Clinically Apparent Stroke at 7 Days
Time frame: at 7 days
Presence of Radiographic Infarcts
Time frame: up to 10 days
Total Infarct Volume
Time frame: Day 7
Decline in Overall Neurocognition
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Executive Function Domain at 90 Day
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days
Time frame: baseline and 90 days
Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days
Time frame: baseline and 90 days
Modified Rankin Scale >2 at 90 Days
Time frame: 90 days
Barthel Index <= 80
Time frame: 90 days
Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days
Time frame: 7 days
Mortality by 90 Days
Time frame: up to 90 days
Length of Stay for Index Hospitalization
Time frame: up to 90 days
Hospital Readmissions
Time frame: up to 90 days
Quality of Life - Physical Health Composite
Time frame: at 90 days
Quality of Life - Mental Health Composite
Time frame: at 90 days
Number of Participants With Emboli Captured
Time frame: day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35483981Messe SR, Overbey JR, Thourani VH, Moskowitz AJ, Gelijns AC, Groh MA, Mack MJ, Ailawadi G, Furie KL, Southerland AM, James ML, Moy CS, Gupta L, Voisine P, Perrault LP, Bowdish ME, Gillinov AM, O'Gara PT, Ouzounian M, Whitson BA, Mullen JC, Miller MA, Gammie JS, Pan S, Erus G, Browndyke JN; Cardiothoracic Surgical Trials Network (CTSN) Investigators. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement. J Thorac Cardiovasc Surg. 2024 Feb;167(2):624-633.e4. doi: 10.1016/j.jtcvs.2022.01.053. Epub 2022 Mar 18.
- Derived from this study: PubMed 30007783Crestanello JA. "Not in my brain": The use of embolic protection devices to prevent brain embolization during cardiovascular procedures. J Thorac Cardiovasc Surg. 2018 Dec;156(6):e205-e206. doi: 10.1016/j.jtcvs.2018.05.114. Epub 2018 Jun 23. No abstract available.
- Derived from this study: PubMed 28787505Mack MJ, Acker MA, Gelijns AC, Overbey JR, Parides MK, Browndyke JN, Groh MA, Moskowitz AJ, Jeffries NO, Ailawadi G, Thourani VH, Moquete EG, Iribarne A, Voisine P, Perrault LP, Bowdish ME, Bilello M, Davatzikos C, Mangusan RF, Winkle RA, Smith PK, Michler RE, Miller MA, O'Sullivan KL, Taddei-Peters WC, Rose EA, Weisel RD, Furie KL, Bagiella E, Moy CS, O'Gara PT, Messe SR; Cardiothoracic Surgical Trials Network (CTSN). Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):536-547. doi: 10.1001/jama.2017.9479.
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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.
Annetine C Gelijns, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Richard Weisel, MD study chair
Toronto General Hospital
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embol-X Embolic Protection Device and CardioGard Cannula in people with Aortic Stenosis and Brain Infarction, run by Icahn School of Medicine at Mount Sinai at 18 sites in 2 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 4 inclusion and 10 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 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada. 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 29 Apr 2019). 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?
Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction (time frame: up to 10 days post procedure). 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 NCT02389894, 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 29 Apr 2019.