Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)
This study has been completed.
Sponsor:
CoAxia
Information provided by:
CoAxia
ClinicalTrials.gov Identifier:
NCT00119717
First received: July 7, 2005
Last updated: May 16, 2011
Last verified: May 2011
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Purpose
The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebrovascular Accident |
Device: NeuroFlo™ catheter Other: Control |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) |
Further study details as provided by CoAxia:
Primary Outcome Measures:
- The safety of the NeuroFlo device and procedure will be compared to medical management alone [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Efficacy will be assessed using a global outcome score [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Acute improvement in neurological function [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Stroke Impact Scale [ Time Frame: 30 & 90 days ] [ Designated as safety issue: No ]
- Hospital length of stay [ Time Frame: Varies ] [ Designated as safety issue: No ]
- Patient disposition upon discharge will be compared [ Time Frame: Varies ] [ Designated as safety issue: No ]
| Enrollment: | 515 |
| Study Start Date: | June 2005 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: NeuroFlo™ catheter
45 minute treatment
|
| Active Comparator: 2 |
Other: Control
ASA Guidelines
|
Detailed Description:
The study is a prospective, controlled, randomized, single-blind, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization will be 1:1 and stratified to ensure equivalent patient distribution between treatment and control for the following key parameters:
- National Institute of Health Stroke Scale (NIHSS) at baseline (stratify <10, 11-18)
- Time from symptom onset (TFSO) to time of baseline NIHSS evaluation (stratify <5 hrs, or ≥5 hrs).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ischemic stroke
- NIHSS between 5-18
- Time from symptom onset less than 14 hours
Exclusion Criteria:
- Hemorrhagic stroke
- Certain types of heart disease
- Kidney disease
- Other conditions the doctor will assess
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119717
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| United States, Alabama | |
| Huntsville Hospital | |
| Huntsville, Alabama, United States, 35801 | |
| United States, California | |
| UCLA | |
| Los Angeles, California, United States, 90024 | |
| Good Samaritan Hospital | |
| San Jose, California, United States, 95124 | |
| United States, Florida | |
| Morton Plant Hospital | |
| Clearwater, Florida, United States, 33756 | |
| University of Florida | |
| Jacksonville, Florida, United States, 32209 | |
| Univ. of Miami | |
| Miami, Florida, United States, 33136 | |
| Munroe Regional Medical Center | |
| Ocala, Florida, United States, 34471 | |
| Sarasota Memorial Hospital | |
| Sarasota, Florida, United States, 34329 | |
| United States, Hawaii | |
| The Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Advocate Lutheran General Hospital | |
| Park Ridge, Illinois, United States, 60068 | |
| Central DuPage Hospital | |
| Winfield, Illinois, United States, 60190 | |
| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Michigan | |
| Michigan State University | |
| Lansing, Michigan, United States, 48824 | |
| St. Joseph Mercy - Oakland | |
| Pontiac, Michigan, United States, 48341 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| Providence Hospital | |
| Southfield, Michigan, United States, 48034 | |
| United States, Minnesota | |
| Abbott Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Missouri | |
| St. Luke's Hospital | |
| Kansas City, Missouri, United States, 64111 | |
| St. Louis University | |
| St. Louis, Missouri, United States, 63110 | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Sunrise Medical Center | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| JFK Medical Center | |
| Edison, New Jersey, United States, 08818 | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| Rochester General Hospital | |
| Rochester, New York, United States, 14621 | |
| SUNY-Upstate Medical Univ. | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Univeristy of North Carolina | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233 | |
| Moses H. Cone Memorial Hospital | |
| Greensboro, North Carolina, United States, 27401 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Sacred Heart Medical Center | |
| Springfield, Oregon, United States, 97477 | |
| United States, Pennsylvania | |
| Penn State Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Lancaster General Hospital | |
| Lancaster, Pennsylvania, United States, 17604 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Wellmont Holston Valley Medical Center | |
| Kingsport, Tennessee, United States, 37660 | |
| St. Thomas Hospital | |
| Nashville, Tennessee, United States, 37205 | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Brackenridge Hospital/Seton Medical Center | |
| Austin, Texas, United States, 78759 | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Neurological Associates/CJW Med Ctr | |
| Richmond, Virginia, United States, 23226 | |
| Sentara Virginia Beach General Hospital | |
| Virginia Beach, Virginia, United States, 23454 | |
| Winchester Medical Center | |
| Winchester, Virginia, United States, 22601 | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98122 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Austria | |
| AKH General Hospital | |
| Linz, Austria | |
| Christian-Doppler-Klinik | |
| Salzburg, Austria | |
| Donauklinikum Tulln | |
| Tulln, Austria | |
| Belgium | |
| ZNA Middelheim | |
| Antwerpen, Belgium | |
| AZ St Jan Brugge | |
| Brugge, Belgium | |
| UZ Gasthuisberg | |
| Leuven, Belgium | |
| Canada, Alberta | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, Ontario | |
| University of Western Ontario | |
| London, Ontario, Canada, N6A 5A5 | |
| Trillium Health Centre | |
| Mississauga, Ontario, Canada, L5B 1B8 | |
| Germany | |
| Klinikum Köln-Merheim | |
| Cologne, Germany | |
| Universitatsklinikum Erlangen | |
| Erlangen, Germany | |
| Universitatsklinikum Duisberg-Essen | |
| Essen, Germany | |
| Universitätsklinikum Heidelberg | |
| Heidelberg, Germany | |
| Universitatsklinikum Mannheim | |
| Mannheim, Germany | |
| Dr. Horst Schmidt Kliniken | |
| Wiesbaden, Germany | |
| Hungary | |
| Medical Health and Science Center, University Of Debrecen | |
| Debrecen, Hungary | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel | |
| Hadassah Hebrew University | |
| Jerusalem, Israel | |
| Sourasky Medical Center | |
| Tel Aviv, Israel | |
| Chaim Sheba Medical Center | |
| Tel Hashomer, Israel | |
| Puerto Rico | |
| University of Puerto Rico | |
| San Juan, Puerto Rico, 00935 | |
| Spain | |
| Hospital Germans Trias i Pujol | |
| Badalona, Spain | |
| Hospital Universitari Vall d'Hebron | |
| Barcelona, Spain | |
| Switzerland | |
| InselSpital | |
| Bern, Switzerland | |
| CHUV | |
| Lausanne, Switzerland | |
Sponsors and Collaborators
CoAxia
Investigators
| Principal Investigator: | Ashfaq Shuaib, MD | University of Alberta, Edmonton |
More Information
Additional Information:
Publications:
| Responsible Party: | Ashfaq Shuaib, MD, University of Alberta, Edmonton |
| ClinicalTrials.gov Identifier: | NCT00119717 History of Changes |
| Other Study ID Numbers: | CD-0125 |
| Study First Received: | July 7, 2005 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Israel: Ministry of Health |
Keywords provided by CoAxia:
|
acute ischemic stroke |
randomized device treatment |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013