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Silk Road Medical First in Man Study - Neuroprotection During Carotid Stenting and Angioplasty

NCT01264419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-02-17

Study results available
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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 by Parodi, et al., as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Criado, et al., developed a derivative technique that employs carotid flow reversal prior to traversing the stenosis and can be accomplished by directly accessing carotid anatomy without the use of the transfemoral approach. Major benefits to this method include the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.

Conditions

  • Carotid Artery Diseases

Interventions

DEVICE

Silk Road Embolic Protection System

System that delivers a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease

Sponsors & Collaborators

  • Silk Road Medical

    lead INDUSTRY

Principal Investigators

  • Sumaira Macdonald, MD, PhD · Chief Medical Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01264419 on ClinicalTrials.gov