Carotid Stenosis
Conditions
Keywords
Carotid stenosis, Intracranial Embolism, Carotid artery, Carotid stent, Embolic protection, TriActiv ProGuard System, Carotid angioplasty
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.
Detailed description
Patients with certain anatomic or medical conditions have a greater risk of serious complications following carotid endarterectomy (a surgical procedure that removes blockages in the carotid artery). Recently, these patients have been treated effectively with the implantation of a carotid stent (a metallic mesh tube). When implanting the carotid stent, physicians use devices called embolic protection devices to prevent particles from the blockage from flowing up to the brain. The TriActiv® ProGuard™ System is an embolic protection device that uses a small balloon to temporarily stop blood flow within the diseased carotid artery while the stent is implanted. Then, the TriActiv® ProGuard™ System removes any particles that may have been released from the blockage during stent implantation before blood flow is restored. This study will evaluate the safety and efficacy of the TriActiv® ProGuard™ System during carotid stent placement in patients who are considered to be at a high risk for complications from surgical endarterectomy.
Interventions
DEVICECarotid Stent Implantation
DEVICEEmbolic Protection
Sponsors
Kensey Nash Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany, United States
Outcome results
None listed