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Concentric Retriever Device (CRD) in Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Concentric Retriever Device
Sponsored by
Sidney Starkman
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Concentric Retriever Device, embolectomy, acute ischemic stroke, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • University of California, Los Angeles

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
September 13, 2005
Last Updated
December 10, 2015
Sponsor
Sidney Starkman
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1. Study Identification

Unique Protocol Identification Number
NCT00203710
Brief Title
Concentric Retriever Device (CRD) in Acute Ischemic Stroke
Official Title
A Single-Center Controlled Registry to Evaluate the Concentric Retriever System for the Treatment of Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sidney Starkman

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Concentric Retriever Device, embolectomy, acute ischemic stroke, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Concentric Retriever Device
Primary Outcome Measure Information:
Title
Achievement of recanalization (TIMI/TICI grade II or III flow) immediately post procedure.
Title
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 Outcome Measure Information:
Title
Assessment of patient's neurological condition and functional state using the NIHSS, Barthel Index, and
Title
Modified Rankin at 30 and 90 days post-procedure.
Title
A composite of major adverse events at 30 and 90 days post-procedure. Major adverse events are defined as death and new stroke.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

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Concentric Retriever Device (CRD) in Acute Ischemic Stroke

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