Clinical Trial: Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.

Brief Summary: The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.

Detailed Summary:

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.


Sponsor: Silk Road Medical

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

Information By: Silk Road Medical

Dates:
Date Received: September 10, 2012
Date Started: November 2012
Date Completion:
Last Updated: March 3, 2017
Last Verified: March 2017