NCT02536378
Completed
Not Applicable
POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE. The ROADSTER 2 Study.
ConditionsCarotid Artery Disease
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Silk Road Medical
- Enrollment
- 692
- Locations
- 43
- Primary Endpoint
- Number of Participants With Procedural Success
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A. Contralateral carotid artery occlusion B. Tandem stenoses \>70% C. High cervical carotid artery stenosis D. Restenosis after carotid endarterectomy E. Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment.
- •F. Hostile Necks which the Investigator deems safe for transcarotid access including but not limited to:
- •I. Prior neck irradiation II. Radical neck dissection III. Cervical spine immobility
- •Clinical High Risk Inclusion Criteria:
- •G. Patient is \> 75 years of age H. Patient has \> 2-vessel coronary artery disease and history of angina of any severity I. Patient has a history of angina
- •Canadian Cardiovascular Society (CCS) angina class 3 or 4 or
- •unstable angina
- •J. Patient has congestive heart failure (CHF) - New York Heart Association (NYHA)
- •Functional Class III or IV
- •K. Patient has known severe left ventricular dysfunction
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Procedural Success
Time Frame: 30 Days
Procedural success is defined as acute device success (successful insertion of the ENROUTE NPS and establishment of flow reversal), technical success (deployment of interventional tools) and the absence of a major adverse events (hierarchical stroke/death/myocardial infarction) through 30 days.
Secondary Outcomes
- Number of Participants Experiencing Major Adverse Event(30 days)
- Number of Participants With Acute Device Success(2 hours (periprocedural))
- Number of Participants With Technical Success(2 hours (periprocedural))
- Number of Participants in Which a Cranial Nerve Injury Occurred(90 days (extended follow-up))
Investigators
Study Sites (43)
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