Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure
The purpose of this study is to evaluate the safety and effectiveness of the MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) in providing cerebral embolic protection during carotid artery stenting. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.|
- Stroke, Myocardial Infarction, and Death [ Time Frame: 30 days post procedure ] [ Designated as safety issue: Yes ]The primary endpoint for overall evaluation of the study is a composite endpoint consisting of the first occurrence of any of the following major adverse events within 30 days.
- Technical Success [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
- Acute Device Success [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
- Procedural Success [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
- Access Site Complications [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]
- Contrast Usage [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: MICHI NPS+f
The MICHI™ NPS+f is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify to the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.
Device: MICHI NPS+f
Cerebral protection with carotid flow reversal
Other Name: MICHI NPS+f
Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy (CEA). Many currently available embolic protection devices, however, have limited efficacy in capturing microembolic debris that is liberated during stenting, pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the need to cross the lesion prior to deployment. Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed.
Cerebral protection with carotid flow reversal is a method that was developed as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Another technique developed employs carotid flow reversal prior to traversing the stenosis and can be accomplished by directly accessing the carotid anatomy without the use of the transfemoral approach. Major benefits to this method include a simpler route to the target lesion and the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jennifer Finn, RN 617-726-4957 email@example.com|
|Principal Investigator: Christopher Kwolek, MD|
|Principal Investigator:||Christopher Kwolek, MD||Massachusetts General Hospital|
|Principal Investigator:||Richard Cambria, MD||Massachusetts General Hospital|