Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)
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|ClinicalTrials.gov Identifier: NCT01685567|
Recruitment Status : Completed
First Posted : September 14, 2012
Results First Posted : March 6, 2017
Last Update Posted : July 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Disease||Device: MICHI NPS+f||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||219 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||July 2016|
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: ENROUTE Transcarotid Neuroprotection System
- Hierarchical Composite of Stroke, Myocardial Infarction, and Death [ Time Frame: 30-day post-procedure ]The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.
- All Death (Non-hierarchical) [ Time Frame: 0 to 30 days ]The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
- All Myocardial Infarctions (Non-hierarchical) [ Time Frame: 0 to 30 days ]The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
- All Stroke (Non-hierarchical) [ Time Frame: 0 to 30 days ]The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
- Ipsilateral Stroke (Non-hierarchical) [ Time Frame: 31-365 days ]Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685567
|Principal Investigator:||Christopher Kwolek, MD||Massachusetts General Hospital|
|Principal Investigator:||Richard Cambria, MD||Massachusetts General Hospital|