Carotid Artery StenosisPhase 3NCT00318851
Carotid Artery Stenting With Protection Registry
A Phase 3 study testing Carotid Stent with Distal Protection Device in people with Carotid Artery Stenosis, run by Providence Health & Services at 1 site in United States.
Trial summary
The purpose of this study is to evaluate ischemic events and neuropsychological changes after carotid artery angioplasty and stenting with a neuroprotection device. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Carotid Stent with Distal Protection Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2007
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 and less than 90
- Symptomatic as evidenced by transient ischemic attack or non-disabling stroke in the hemisphere supplied by the target vessel within 180 days of procedure. Must have anatomic stenosis greater than 70% by ultrasound or angiography performed in previous 30 days
- Asymptomatic patients with a stenosis greater than 80% by ultrasound or angiography performed in previous 30 days
- Patient has no childbearing potential or has negative pregnancy tests within one week prior to procedure.
- Patient and patient's physician agree to have the patient return for all the required clinical contacts following study enrollment
- Patient signs informed consent
- Patient has been excluded from other multi-institutional trials
Who cannot join
- Patient has evolving stroke or intracranial hemorrhage
- Allergy to trial required medications
- Active bleeding diathesis or coagulopathy, or will refuse blood transfusions
- History of major ipsilateral stroke with sufficient atrophy to increase risk of procedure associated bleed
- Severe dementia
- Previous intracranial hemorrhage or brain surgery within the past twelve months
Show all 13Show fewer
- Patient has any condition that precludes angiography or would make a percutaneous procedure unsafe
- Patient or family inability to understand or cooperate with study procedures
- Recent GI or remote bleed that would interfere with anti-plate therapy
- Severe vessel tortuosity or calcification that would preclude introduction of guiding catheter, guiding sheath, or stent placement
- Extensive diffuse atherosclerotic disease involving the arch or common carotid that would preclude safe introduction of catheters and sheaths for endovascular therapy
- Intraluminal filling defect
- Intracranial aneurysm greater than 6 mm, AVM, or other intracranial vascular abnormality that would preclude safe intravascular intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Sacred Heart Medical Center
Spokane, Washington, 99204
About this study
Official title: Treatment of Carotid Stenosis With Carotid Stenting and Neurologic Protection With Pre-Procedure and Follow-Up With MRI DIffusion Imaging and Neuropsychological Testing
The purpose of this study is to evaluate ischemic events and neuropsychological changes after carotid artery angioplasty and stenting with a neuroprotection device.
Read the detailed description
Stroke is the third most common cause of death in North America with approximately 750,000 new strokes reported annually, of which 150,000 are fatal. Approximately 75% of strokes occur in the distribution of the carotid arteries. Among those, a thrombotic etiology (carotid occlusive disease) is one of the most common causes. Recently published studies have shown that patients who underwent carotid stenting in combination with a cerebral protection device had better overall outcomes as related to stroke, death and MI as opposed to carotid endarterectomy. What is not known is whether protection devices which allow some particles (100 micron particle size or less) to pass through the filter or particles that embolize during placement or removal of the protection device, will have any delayed abnormal outcomes as determined by neuropsychological testing.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Carotid Stent with Distal Protection Device
- Keywords
- Carotid Artery stenting, Stroke
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Stent with Distal Protection DeviceDevice
Also called Carotid Artery Stenting, Neurocognitive evaluation in Carotid Artery Stenting
Carotid Stent Placement with Distal Protection
| Study group | Role | What they receive |
|---|---|---|
| Carotid Artery Stenting | Experimental | Not described Receives: Device: Carotid Stent with Distal Protection Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new diffusion weighted abnormalities post-procedure
Measured: 24 hours post stent placement
Secondary outcomes (14)
Neuropsychological stability or deterioration
Measured: 3 months post procedure
Neuropsychological stability or deterioration
Measured: 6 months post procedure
Neuropsychological stability or deterioration
Measured: 12 months post procedure
Acute versus delayed neuropsychological changes
Measured: 1-7 days post procedure
Acute versus delayed neuropsychological changes
Measured: 3 months post procedure
Acute versus delayed neuropsychological changes
Measured: 6 months post procedure
Acute versus delayed neuropsychological changes
Measured: 12 months post procedure
Stroke and death
Measured: 1 month
Stroke and death
Measured: 6 months
Stroke and death
Measured: 12 months
NIH stroke scale changes
Measured: 24 hours post procedure
NIH stroke scale changes
Measured: 1 month post procedure
NIH stroke scale changes
Measured: 6 months post procedure
NIH stroke scale changes
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startSep 2003
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Investigators
- Rodney D. Raabe, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318851
- Sponsor's protocol ID
- HI473
- Status last verified
- Mar 2006
- First submitted
- 25 Apr 2006
- Last updated
- 26 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Carotid Stenosis With Carotid Stenting and Neurologic Protection With Pre-Procedure and Follow-Up With MRI DIffusion Imaging and Neuropsychological Testing
- ClinicalTrials.gov ID
- NCT00318851
- Acronym / sponsor ID
- HI473
- Conditions
- Carotid Artery Stenosis
- Keywords
- Carotid Artery stenting, Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Apr 2006 (estimated)
- 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.
The purpose of this study is to evaluate ischemic events and neuropsychological changes after carotid artery angioplasty and stenting with a neuroprotection device.
Detailed description
Stroke is the third most common cause of death in North America with approximately 750,000 new strokes reported annually, of which 150,000 are fatal. Approximately 75% of strokes occur in the distribution of the carotid arteries. Among those, a thrombotic etiology (carotid occlusive disease) is one of the most common causes. Recently published studies have shown that patients who underwent carotid stenting in combination with a cerebral protection device had better overall outcomes as related to stroke, death and MI as opposed to carotid endarterectomy. What is not known is whether protection devices which allow some particles (100 micron particle size or less) to pass through the filter or particles that embolize during placement or removal of the protection device, will have any delayed abnormal outcomes as determined by neuropsychological testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Artery Stenting | Experimental | Device: Carotid Stent with Distal Protection Device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than 18 and less than 90
- Symptomatic as evidenced by transient ischemic attack or non-disabling stroke in the hemisphere supplied by the target vessel within 180 days of procedure. Must have anatomic stenosis greater than 70% by ultrasound or angiography performed in previous 30 days
- Asymptomatic patients with a stenosis greater than 80% by ultrasound or angiography performed in previous 30 days
- Patient has no childbearing potential or has negative pregnancy tests within one week prior to procedure.
- Patient and patient's physician agree to have the patient return for all the required clinical contacts following study enrollment
Key exclusion criteria (13 listed)
- Patient has evolving stroke or intracranial hemorrhage
- Allergy to trial required medications
- Active bleeding diathesis or coagulopathy, or will refuse blood transfusions
- History of major ipsilateral stroke with sufficient atrophy to increase risk of procedure associated bleed
- Severe dementia
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 |
|---|---|---|
| Carotid Stent with Distal Protection DeviceAlso: Carotid Artery Stenting, Neurocognitive evaluation in Carotid Artery StentingCarotid Stent Placement with Distal Protection | Device | Carotid Artery Stenting |
Primary outcome
Number of new diffusion weighted abnormalities post-procedure
Time frame: 24 hours post stent placement
14 secondary outcomes
Neuropsychological stability or deterioration
Time frame: 3 months post procedure
Neuropsychological stability or deterioration
Time frame: 6 months post procedure
Neuropsychological stability or deterioration
Time frame: 12 months post procedure
Acute versus delayed neuropsychological changes
Time frame: 1-7 days post procedure
Acute versus delayed neuropsychological changes
Time frame: 3 months post procedure
Acute versus delayed neuropsychological changes
Time frame: 6 months post procedure
Acute versus delayed neuropsychological changes
Time frame: 12 months post procedure
Stroke and death
Time frame: 1 month
Stroke and death
Time frame: 6 months
Stroke and death
Time frame: 12 months
NIH stroke scale changes
Time frame: 24 hours post procedure
NIH stroke scale changes
Time frame: 1 month post procedure
NIH stroke scale changes
Time frame: 6 months post procedure
NIH stroke scale changes
Time frame: 12 months post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2010.
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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.
Rodney D. Raabe, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carotid Stent with Distal Protection Device in people with Carotid Artery Stenosis, run by Providence Health & Services at 1 site in United States.
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 7 inclusion and 13 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 26 Aug 2010. 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 United States. 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.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of new diffusion weighted abnormalities post-procedure (time frame: 24 hours post stent placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2010.