Clinical Trial: POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE. The ROADSTER 2 Study.

Brief Summary: The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.

Detailed Summary:
Sponsor: Silk Road Medical

Current Primary Outcome: Rate of procedural success through 30 days following stent implant [ Time Frame: 30 Days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Silk Road Medical

Dates:
Date Received: August 27, 2015
Date Started: September 2015
Date Completion: June 2018
Last Updated: March 16, 2017
Last Verified: March 2017