Ischemic StrokePhase 2/3VISSITNCT00816166
VISSIT Intracranial Stent Study for Ischemic Therapy
A Phase 2/3 study testing Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel) and Aspirin and Clopidogrel (Medical therapy) in people with Ischemic Stroke and Transient Ischemic Attack, run by Codman & Shurtleff.
Trial summary
The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel) and Aspirin and Clopidogrel (Medical therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Jun 2014
- Phase
- Phase 2/3
- 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
- Subject has at least one neurovascular lesion (70-99%) stenosis [internal carotid, middle cerebral, vertebral artery (C4-BA), and/or basilar artery] symptomatic with a hard TIA or stroke attributable to the territory of the lesion within the past 30 days. An intracranial tandem lesion (50-99%) stenosis may be treated if normal artery segment is sufficient length to avoid overlapping stents.
- Target vessel diameter / lesion length measurements are within one of the below per angiogram:
- Vessel diameter is ≥ 2.0 mm and < 2.5 mm / lesion length is ≤ 16 mm, or
- Vessel diameter is ≥ 2.5 mm and < 3.0 mm / lesion length is ≤ 18 mm, or
- Vessel diameter is ≥ 3.0 mm and < 4.5 mm / lesion length is ≤ 26 mm, or
- Vessel diameter is ≥ 4.5 mm and ≤ 5.0 mm / lesion length is ≤ 31 mm
Show all 12Show fewer
- Subject has normal artery adjacent to each stenosis; diameter 2.0 mm - 5.0 mm
- Subject age is 18-85 years
- Life expectancy is at least 2 years
- Subject 's mRS score is ≤ 3
- Subject is available for study follow-up visits (e.g., lives within 3 hours of research center)
- Subject is willing and cognitively able to provide Informed Consent (consent may be indicated verbally and signed by neutral witness if stroke has impaired hand or visual function)
Who cannot join
- Subject has contraindications for balloon expandable stent, e.g.
- Extreme tortuosity at, or proximal to, target lesion,
- More than 2 lesions with > 50% stenosis (including vertebral ostia and common carotid disease),
- Carotid or vertebral dissection
- CT scan or MRI evidence of any of the following:
- Intracranial hemorrhage of type PH1 or PH2
Show all 29Show fewer
- Subdural or epidural hemorrhage
- Mass effect, or
- Intracranial tumor (except small meningioma)
- Subject has a previous stent in the territory of the target lesion(s)
- Subject has a previous coil or clip placed in the territory of the target lesion within 6 months
- Subject has a potential source of cardiac embolism requiring anticoagulation therapy (e.g., atrial fibrillation, intracardiac thrombus or vegetation, significant mitral stenosis, mechanical heart valve, congestive heart failure with EF <30%, or endocarditis)
- Subject has concurrent intracranial pathology, e.g.
- Moyamoya
- Vasculitis documented by biopsy results
- Ruptured Aneurysm
- Unruptured aneurysm > 7mm
- Subject has uncontrolled hypertension (systolic >185 mmHg or diastolic >110 mmHg)
- Hemoglobin < 10 g/dL; platelet count < 100,000; or INR > 1.5 (e.g., use of warfarin)
- Subject has an uncorrectable bleeding diathesis
- Subject's neurological status is unstable and rapidly declining (NIHSS score increased > 4 points within 48 hours prior to randomization)
- Subject has a contraindication for combination antithrombotic treatment (e.g., clopidogrel and aspirin) such as peptic ulcer disease
- Subject history indicates high risk of non-compliance (e.g., substance abuse, psychosocial issues, etc.)
- Subject has a known history contraindicating contrast dye or iodine (vs. sensitivity which can be safely controlled by antihistamine, steroid, etc.)
- Subject is pregnant or plans to become pregnant in the next 12 months
- Myocardial infarction within past 3 months
- Treatment with tPA or other thrombolytic agent within 48 hours prior to randomization
- Major surgery or trauma within 2 weeks prior to randomization
- Enrollment in another investigational device or drug study that may confound the results
About this study
Official title: Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease
The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial.
A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.
Read the detailed description
1.1 Study Hypothesis Treatment of cerebral or retinal ischemia due to plaque in the neurovasculature using the PHAROS Vitesse Stent System plus medical therapy will provide additional clinical benefit over medical therapy alone.
1.2 Primary Effectiveness Endpoint
The primary effectiveness endpoint consists of a composite of the two following outcomes:
- Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization
- Hard TIA in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization
1.3 Safety Outcomes
Safety outcomes to be collected and reported as part of the overall risk-to-benefit profile for this device are:
- Stroke in any territory within 30 days of randomization
- Death from any cause within 30 days of randomization
- Hard TIA in any territory occurring after a 24 hour post-procedure stabilization period (days 2-30) since the recovery from anesthesia can mask accurate assessment of possible TIA symptoms.
- Intracranial hemorrhage within 30 days of randomization
1.4 Other Outcomes
- Stent Success - PHAROS Vitesse stent deployed across target lesion with residual stenosis 0-20%
- Percentage of Stent Group Subjects with any (symptomatic or asymptomatic) in-stent restenosis ≥ 70% confirmed by angiogram at 12 months
- Percentage of Stent Group Subjects with symptomatic in-stent restenosis ≥ 70% confirmed by angiogram at 12 months
- Percentage of Medical Therapy Group Subjects with interventional procedure (e.g., angioplasty or stent) at 12 months
- Comparison of NIHSS scores between treatment arms
- Comparison of mRS scores between treatment arms
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Being tested
- Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel), Aspirin and Clopidogrel (Medical therapy)
- Keywords
- Ischemic stroke, Transient Ischemic Attack, Intracranial Stenting
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)Device
Also called Pharos Vitesse Neurovascular Stent System, Asprin, Clopidogrel, Plavix(r)
Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions + Medical therapy [Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)]
Aspirin and Clopidogrel (Medical therapy)Drug
Also called Aspirin, Clopidogrel, Plavix(r)
Medical therapy alone [Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)]
| Study group | Role | What they receive |
|---|---|---|
| Stent Group | Experimental | Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group") Receives: Device: Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel) |
| Medical Therapy Group | Active comparator | Medical therapy alone ("Medical Therapy Group") Receives: Drug: Aspirin and Clopidogrel (Medical therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months
The primary effectiveness endpoint was a composite of the two following outcomes:
- Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization
- Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization
A subject was deemed to be a primary endpoint success if neither of these outcomes occurred.
The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months).
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2013
- Study completionJun 2014
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 (7)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codman & Shurtleff
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816166
- Sponsor's protocol ID
- VISSIT CA-2007-01
- Other IDs
- G080051
- Acronym
- VISSIT
- Status last verified
- Feb 2015
- First submitted
- 29 Dec 2008
- Last updated
- 20 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Berkefeld J, Hamann GF, du Mesnil R, Kurre W, Steinmetz H, Zanella FE, Sitzer M. [Endovascular treatment for intracranial stenoses. A common statement by neurologists and neuroradiologists]. Nervenarzt. 2006 Dec;77(12):1444-55. doi: 10.1007/s00115-006-2182-z. German.
PubMed 17119891Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.
PubMed 15800226Cruz-Flores S, Diamond AL. Angioplasty for intracranial artery stenosis. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD004133. doi: 10.1002/14651858.CD004133.pub2.
PubMed 16856032Derdeyn CP, Chimowitz MI. Angioplasty and stenting for atherosclerotic intracranial stenosis: rationale for a randomized clinical trial. Neuroimaging Clin N Am. 2007 Aug;17(3):355-63, viii-ix. doi: 10.1016/j.nic.2007.05.001.
PubMed 17826637Fiorella D, Chow MM, Anderson M, Woo H, Rasmussen PA, Masaryk TJ. A 7-year experience with balloon-mounted coronary stents for the treatment of symptomatic vertebrobasilar intracranial atheromatous disease. Neurosurgery. 2007 Aug;61(2):236-42; discussion 242-3. doi: 10.1227/01.NEU.0000255521.42579.31.
PubMed 17762735Fiorella D, Woo HH. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. Stroke. 2007 Aug;38(8):2391-6. doi: 10.1161/STROKEAHA.107.482752. Epub 2007 Jun 21. No abstract available.
PubMed 17585085Zaidat OO, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, Gupta R, Kirshner H, Megerian JT, Lesko J, Pitzer P, Ramos J, Castonguay AC, Barnwell S, Smith WS, Gress DR; VISSIT Trial Investigators. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA. 2015 Mar 24-31;313(12):1240-8. doi: 10.1001/jama.2015.1693.
PubMed 25803346
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease
- ClinicalTrials.gov ID
- NCT00816166
- Acronym / sponsor ID
- VISSIT / VISSIT CA-2007-01
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Keywords
- Ischemic stroke, Transient Ischemic Attack, Intracranial Stenting
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Codman & ShurtleffIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Dec 2008 (estimated)
- Results
- Posted 16 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial.
A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.
Detailed description
1.1 Study Hypothesis Treatment of cerebral or retinal ischemia due to plaque in the neurovasculature using the PHAROS Vitesse Stent System plus medical therapy will provide additional clinical benefit over medical therapy alone.
1.2 Primary Effectiveness Endpoint
The primary effectiveness endpoint consists of a composite of the two following outcomes:
- Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization
- Hard TIA in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization
1.3 Safety Outcomes
Safety outcomes to be collected and reported as part of the overall risk-to-benefit profile for this device are:
- Stroke in any territory within 30 days of randomization
- Death from any cause within 30 days of randomization
- Hard TIA in any territory occurring after a 24 hour post-procedure stabilization period (days 2-30) since the recovery from anesthesia can mask accurate assessment of possible TIA symptoms.
- Intracranial hemorrhage within 30 days of randomization
1.4 Other Outcomes
- Stent Success - PHAROS Vitesse stent deployed across target lesion with residual stenosis 0-20%
- Percentage of Stent Group Subjects with any (symptomatic or asymptomatic) in-stent restenosis ≥ 70% confirmed by angiogram at 12 months
- Percentage of Stent Group Subjects with symptomatic in-stent restenosis ≥ 70% confirmed by angiogram at 12 months
- Percentage of Medical Therapy Group Subjects with interventional procedure (e.g., angioplasty or stent) at 12 months
- Comparison of NIHSS scores between treatment arms
- Comparison of mRS scores between treatment arms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent Group | Experimental | Device: Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group") |
| Medical Therapy Group | Active comparator | Drug: Aspirin and Clopidogrel (Medical therapy)Medical therapy alone ("Medical Therapy Group") |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject has at least one neurovascular lesion (70-99%) stenosis [internal carotid, middle cerebral, vertebral artery (C4-BA), and/or basilar artery] symptomatic with a hard TIA or stroke attributable to the territory of the lesion within the past 30 days. An intracranial tandem lesion (50-99%) stenosis may be treated if normal artery segment is sufficient length to avoid overlapping stents.
- Target vessel diameter / lesion length measurements are within one of the below per angiogram:
- Subject has normal artery adjacent to each stenosis; diameter 2.0 mm - 5.0 mm
- Subject age is 18-85 years
- Life expectancy is at least 2 years
Key exclusion criteria (29 listed)
- Subject has contraindications for balloon expandable stent, e.g.
- CT scan or MRI evidence of any of the following:
- Subject has a previous stent in the territory of the target lesion(s)
- Subject has a previous coil or clip placed in the territory of the target lesion within 6 months
- Subject has a potential source of cardiac embolism requiring anticoagulation therapy (e.g., atrial fibrillation, intracardiac thrombus or vegetation, significant mitral stenosis, mechanical heart valve, congestive heart failure with EF <30%, or endocarditis)
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 |
|---|---|---|
| Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)Also: Pharos Vitesse Neurovascular Stent System, Asprin, Clopidogrel, Plavix(r)Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions + Medical therapy [Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)] | Device | Stent Group |
| Aspirin and Clopidogrel (Medical therapy)Also: Aspirin, Clopidogrel, Plavix(r)Medical therapy alone [Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)] | Drug | Medical Therapy Group |
Primary outcome
Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months
Time frame: One Year
The primary effectiveness endpoint was a composite of the two following outcomes: * Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization * Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization A subject was deemed to be a primary endpoint success if neither of these outcomes occurred. The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17119891Berkefeld J, Hamann GF, du Mesnil R, Kurre W, Steinmetz H, Zanella FE, Sitzer M. [Endovascular treatment for intracranial stenoses. A common statement by neurologists and neuroradiologists]. Nervenarzt. 2006 Dec;77(12):1444-55. doi: 10.1007/s00115-006-2182-z. German.
- Background: PubMed 15800226Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.
- Background: PubMed 16856032Cruz-Flores S, Diamond AL. Angioplasty for intracranial artery stenosis. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD004133. doi: 10.1002/14651858.CD004133.pub2.
- Background: PubMed 17826637Derdeyn CP, Chimowitz MI. Angioplasty and stenting for atherosclerotic intracranial stenosis: rationale for a randomized clinical trial. Neuroimaging Clin N Am. 2007 Aug;17(3):355-63, viii-ix. doi: 10.1016/j.nic.2007.05.001.
- Background: PubMed 17762735Fiorella D, Chow MM, Anderson M, Woo H, Rasmussen PA, Masaryk TJ. A 7-year experience with balloon-mounted coronary stents for the treatment of symptomatic vertebrobasilar intracranial atheromatous disease. Neurosurgery. 2007 Aug;61(2):236-42; discussion 242-3. doi: 10.1227/01.NEU.0000255521.42579.31.
- Background: PubMed 17585085Fiorella D, Woo HH. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. Stroke. 2007 Aug;38(8):2391-6. doi: 10.1161/STROKEAHA.107.482752. Epub 2007 Jun 21. No abstract available.
- Derived from this study: PubMed 25803346Zaidat OO, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, Gupta R, Kirshner H, Megerian JT, Lesko J, Pitzer P, Ramos J, Castonguay AC, Barnwell S, Smith WS, Gress DR; VISSIT Trial Investigators. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA. 2015 Mar 24-31;313(12):1240-8. doi: 10.1001/jama.2015.1693.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel) and Aspirin and Clopidogrel (Medical therapy) in people with Ischemic Stroke and Transient Ischemic Attack, run by Codman & Shurtleff.
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 12 inclusion and 29 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 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2014). 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 Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months (time frame: One Year). 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 NCT00816166, which also lists 7 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 20 Feb 2015.