Concentric Retriever Device (CRD) in Acute Ischemic Stroke - Full Text View

Sponsored by:	University of California, Los Angeles
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00203710

Purpose

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.

Condition	Intervention
Acute Ischemic Stroke	Device: Concentric Retriever Device

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single-Center Controlled Registry to Evaluate the Concentric Retriever System for the Treatment of Stroke

Further study details as provided by University of California, Los Angeles:

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.

Estimated Enrollment:	50
Study Start Date:	October 2003
Estimated Study Completion Date:	September 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203710

Locations

United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90024

Sponsors and Collaborators

University of California, Los Angeles

More Information

Additional Information:

UCLA Stroke Center home page This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	UCLA-TR-001
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00203710 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

Concentric Retriever Device
embolectomy
acute ischemic stroke
treatment

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases

Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Pathologic Processes
Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Ischemia
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009