Study Stopped
Sponsor elected to not pursue this indication for the study device.
Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting
Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System
1 other identifier
interventional
400
2 countries
34
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™ System when used during a stent placement in a blockage within the carotid artery in patients considered to be at high risk for complications from surgical endarterectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedFirst Posted
Study publicly available on registry
November 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJuly 25, 2007
July 1, 2007
November 1, 2006
July 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.
Secondary Outcomes (5)
Rate of subject intolerance to prolonged carotid artery occlusion;
Rate of access site complications requiring treatment with blood transfusion or surgical repair.
Rate of successful use of the study device success
Rate of successful lesion treatment
Rate of procedure success
Interventions
Eligibility Criteria
You may qualify if:
- Greater than 18 year of age
- Patient gives informed consent
- Less than 30mm stenosis in the common and/or internal carotid artery: at least a 50% stenosis if symptomatic or at least an 80% stenosis if asymptomatic
- At least one medical or anatomic condition which makes the patient a high surgical risk.
You may not qualify if:
- Stroke within 14 days
- Major stroke with significant residual effects
- Myocardial infarction within 72 hours
- Extensive atherosclerotic disease in the aortic arch or proximal common carotid artery
- Severe carotid artery tortuosity
- Total occlusion
- Presence of thrombus or heavy calcification in the carotid artery
- Pre-existing carotid artery dissection
- Any planned interventional or surgical procedures within 30 days
- Atrial fibrillation
- Creatinine \> 2 mg/dL
- Current participation in another investigational drug or device study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
University of Alabama Birmingham
Birmingham, Alabama, 35294-0012, United States
Thomas Hospital
Fairhope, Alabama, 36532, United States
Brotman Medical Center
Beverly Hills, California, 90210, United States
Good Samaritan Hospital
Los Angeles, California, 90017, United States
El Camino Hospital
Mountain View, California, 94040, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Florida Crdiovascular Research at JFK Medical Center
Atlantis, Florida, 33462, United States
University of Florida
Jacksonville, Florida, 32209, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Mt. Sinai Medical Center
Miami Beach, Florida, 33140, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Crawford Long Hospital
Atlanta, Georgia, 30322, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Millard Fillmore Hospital
Buffalo, New York, 14209, United States
Millard Fillmore
Buffalo, New York, 14209, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Lorain Community Hospital
Elyria, Ohio, 44035, United States
St. John West Shore Hospital
Westlake, Ohio, 44145, United States
Pinnacle Health Hospital
Harrisburg, Pennsylvania, 17110, United States
St. Joseph Medical Center
Wyomissing, Pennsylvania, 19610, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, 29204, United States
Methodist Germantown
Germantown, Tennessee, 38138, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
Baptist Hospital of East Tennessee
Knoxville, Tennessee, 37920, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Virginia Cardiovascular Specialists/St. Mary's Hospital
Richmond, Virginia, 23226, United States
Stadtisches Krankenhaus Neuperlach
Bayern, 81737, Germany
CardioVasculares Centrum Frankfurt Sankt Katharinen
Frankfurt, 60389, Germany
Herzzentrum Hamburg
Hamburg, 22527, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary S Roubin, MD
Lenox Hill Hospital, New York, NY
- PRINCIPAL INVESTIGATOR
Rajesh Dave, MD
Pinnacle Health Hospital, Harrisburg, PA
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 1, 2006
First Posted
November 3, 2006
Study Start
November 1, 2006
Study Completion
June 1, 2007
Last Updated
July 25, 2007
Record last verified: 2007-07