Acute Ischemic StrokeNCT00203710
Concentric Retriever Device (CRD) in Acute Ischemic Stroke
A study testing Concentric Retriever Device in people with Acute Ischemic Stroke, run by Sidney Starkman at 1 site in United States.
Trial summary
The primary purpose is to study the safety and effectiveness of the Concentric Retriever Device(CRD)in ischemic stroke patients who undergo clot retrieval with the CRD within 8 hours of stroke symptom onset. The CRD has been approved by the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Concentric Retriever Device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Sep 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1(a) -Patients who present within 8 hours of stroke onset and are not candidates for treatment with t-PA who have clinical signs consistent with the diagnosis of ischemic stroke such as impairment of language, motor function, sensation, cognition, and/or gaze, or vision.
- 1(b). Patients who have had an acute ischemic stroke treated with intravenous thrombolytic therapy where vascular imaging (TCD, CTA, MRA, angiography) shows a persistent occlusion after the end of the infusion treatment.
- 2. Patients > 18 years of age. 3. NIHSSS > 7 4. Angiogram shows a thrombotic occlusion originating in the internal carotid, middle cerebral (M1 or M2 segment), basilar, posterior cerebral, or vertebral arteries.
- 5. Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
Who cannot join
- Patient is pregnant (if within child bearing age).
- Patient has baseline glucose of < 50mg/dL (<50 mg/mM).
- Patient has excessive arterial tortuosity that precludes the device from reaching the target area.
- Patient has known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 2.0.
- Patient received Heparin within 48 hours with a PTT greater than 2 times the lab normal.
- Patient has baseline platelets < 30,000.
Show all 12Show fewer
- Patient has history of severe allergy to intra-arterial contrast medium.
- Patient has severe, sustained hypertension (systolic blood pressure > 185 mm Hg or diastolic blood pressure > 110 mm Hg).
- NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication (i.e. Nipride), the patient can be enrolled.
- CT Scan or MRI reveals significant mass effect with midline shift.
- Patient's angiogram shows an arterial stenosis (>50%) proximal to the embolus.
- Patient's anticipated life expectancy is less than 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90024
About this study
Official title: A Single-Center Controlled Registry to Evaluate the Concentric Retriever System for the Treatment of Stroke
The primary purpose is to study the safety and effectiveness of the Concentric Retriever Device(CRD)in ischemic stroke patients who undergo clot retrieval with the CRD within 8 hours of stroke symptom onset. The CRD has been approved by the U.S. Food and Drug Administration to retrieve foreign bodies (such as pieces of metal) from blood vessels in the body. The CRD is a small metal wire with a loop at the end (like a corkscrew) that removes clots from arteries and thereby restores blood flow to the brain. Prior versions of the CRD may have been too soft to pull out clots, just as a corkscrew that is too soft would not pull out corks. The current version of the CRD is not as soft and may be more effective in retrieving clots. Hypothesis: By restoring blood flow to the brain, stroke symptoms may get better or the stroke may be prevented from getting worse.
Read the detailed description
The primary objective is to assess the safety and efficacy of the Concentric Retriever in the treatment of thrombotic occlusions originating in the internal carotid, middle cerebral (M1 and M2 segments), basilar, posterior cerebral or vertebral arteries. A maximum of 50 patients may be enrolled at a single site, University of California, Los Angeles.
Primary endpoints: Achievement of recanalization (TIMI/TICI grade II or III flow) immediately post procedure without occurrence of major complications will be assessed. Major complications are defined as vessel perforation, intramural arterial dissection, symptomatic intra-cranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.
Secondary endpoints: Assessment of patient's neurological condition and functional state using the NIHSS, Barthel Index, and Modified Rankin at 30 and 90 days post-procedure. A composite of major adverse events at 30 and 90 days post-procedure will be reported. Major adverse events are defined as death and new stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Concentric Retriever Device
- Keywords
- Concentric Retriever Device, embolectomy, acute ischemic stroke, treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentric Retriever DeviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of recanalization (TIMI/TICI grade II or III flow) immediately post procedure.
In addition, major complications defined as vessel perforation, intramural arterial dissection, symptomatic intra-cranial hemorrhage, and significant embolization in a previously uninvolved arterial territory will be tabulated.
Secondary outcomes (3)
Assessment of patient's neurological condition and functional state using the NIHSS, Barthel Index, and
Modified Rankin at 30 and 90 days post-procedure.
A composite of major adverse events at 30 and 90 days post-procedure. Major adverse events are defined as death and new stroke.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Sidney Starkman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sidney Starkman, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203710
- Sponsor's protocol ID
- UCLA-TR-001
- Status last verified
- Dec 2015
- First submitted
- 13 Sep 2005
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Controlled Registry to Evaluate the Concentric Retriever System for the Treatment of Stroke
- ClinicalTrials.gov ID
- NCT00203710
- Acronym / sponsor ID
- UCLA-TR-001
- Conditions
- Acute Ischemic Stroke
- Keywords
- Concentric Retriever Device, embolectomy, acute ischemic stroke, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Sidney StarkmanUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 20 Sep 2005 (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 primary purpose is to study the safety and effectiveness of the Concentric Retriever Device(CRD)in ischemic stroke patients who undergo clot retrieval with the CRD within 8 hours of stroke symptom onset. The CRD has been approved by the U.S. Food and Drug Administration to retrieve foreign bodies (such as pieces of metal) from blood vessels in the body. The CRD is a small metal wire with a loop at the end (like a corkscrew) that removes clots from arteries and thereby restores blood flow to the brain. Prior versions of the CRD may have been too soft to pull out clots, just as a corkscrew that is too soft would not pull out corks. The current version of the CRD is not as soft and may be more effective in retrieving clots. Hypothesis: By restoring blood flow to the brain, stroke symptoms may get better or the stroke may be prevented from getting worse.
Detailed description
The primary objective is to assess the safety and efficacy of the Concentric Retriever in the treatment of thrombotic occlusions originating in the internal carotid, middle cerebral (M1 and M2 segments), basilar, posterior cerebral or vertebral arteries. A maximum of 50 patients may be enrolled at a single site, University of California, Los Angeles.
Primary endpoints: Achievement of recanalization (TIMI/TICI grade II or III flow) immediately post procedure without occurrence of major complications will be assessed. Major complications are defined as vessel perforation, intramural arterial dissection, symptomatic intra-cranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.
Secondary endpoints: Assessment of patient's neurological condition and functional state using the NIHSS, Barthel Index, and Modified Rankin at 30 and 90 days post-procedure. A composite of major adverse events at 30 and 90 days post-procedure will be reported. Major adverse events are defined as death and new stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1(a) -Patients who present within 8 hours of stroke onset and are not candidates for treatment with t-PA who have clinical signs consistent with the diagnosis of ischemic stroke such as impairment of language, motor function, sensation, cognition, and/or gaze, or vision.
- 1(b). Patients who have had an acute ischemic stroke treated with intravenous thrombolytic therapy where vascular imaging (TCD, CTA, MRA, angiography) shows a persistent occlusion after the end of the infusion treatment.
- 2. Patients > 18 years of age. 3. NIHSSS > 7 4. Angiogram shows a thrombotic occlusion originating in the internal carotid, middle cerebral (M1 or M2 segment), basilar, posterior cerebral, or vertebral arteries.
- 5. Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
Key exclusion criteria (12 listed)
- Patient is pregnant (if within child bearing age).
- Patient has baseline glucose of < 50mg/dL (<50 mg/mM).
- Patient has excessive arterial tortuosity that precludes the device from reaching the target area.
- Patient has known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 2.0.
- Patient received Heparin within 48 hours with a PTT greater than 2 times the lab normal.
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 |
|---|---|---|
| Concentric Retriever Device | Device | – |
Primary outcome
Achievement of recanalization (TIMI/TICI grade II or III flow) immediately post procedure.
In addition, major complications defined as vessel perforation, intramural arterial dissection, symptomatic intra-cranial hemorrhage, and significant embolization in a previously uninvolved arterial territory will be tabulated.
3 secondary outcomes
Assessment of patient's neurological condition and functional state using the NIHSS, Barthel Index, and
Modified Rankin at 30 and 90 days post-procedure.
A composite of major adverse events at 30 and 90 days post-procedure. Major adverse events are defined as death and new stroke.
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 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentric Retriever Device in people with Acute Ischemic Stroke, run by Sidney Starkman 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 4 inclusion and 12 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 14 Dec 2015. 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.
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?
Achievement of recanalization (TIMI/TICI grade II or III flow) immediately post procedure.. 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?
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 14 Dec 2015.