Clinical trial NCT06470815: ROADSTER 3 Extended Follow-up Sub-Study
Official title: Long-Term Follow-up Study of ROADSTER 3 Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Carotid Artery Diseases
Keywords: Long-term Follow-up
TCAR
Lead sponsor: Silk Road Medical
Sponsor class: INDUSTRY
First posted: 2024-06-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who were enrolled in the ROADSTER 3 study

Brief summary: The study objective is to evaluate long-term outcomes for participants enrolled in the ROADSTER 3 study and treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS).

Detailed description: This is an open label, single arm, multi-center post-market study evaluating long-term outcomes for participants at standard risk for adverse events from carotid endarterectomy who underwent carotid revascularization with the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System in the ROADSTER 3 study.

Eligibility criteria: Inclusion Criteria:

* Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
* Able to provide informed consent

Exclusion Criteria:

* Participants who have exited the ROADSTER 3 study early (i.e., prior to completion of protocol required follow-up) will not participate in the sub-study

Primary outcomes:
measure: Ipsilateral Stroke
timeFrame: 2-years, 3-years, 4-years, and 5-years following the index procedure
measure: Ipsilateral Stroke Mortality
timeFrame: 2-years, 3-years, 4-years, and 5-years following the index procedure
measure: In-stent Restenosis
timeFrame: 2-years and 5-years following the index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Valley Vascular Consultants
state: Alabama
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Tucson
country: United States
facility: Pima Heart & Vascular
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego (UCSD)
state: California
city: La Mesa
country: United States
facility: Sharp Grossmont
state: California
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Ocala
country: United States
facility: AdventHealth Ocala
state: Florida
city: Cumming
country: United States
facility: Northside Vascular
state: Georgia
city: Evansville
country: United States
facility: Deaconess Research / Evansville Surgical Associates
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Lafayette
country: United States
facility: Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: McLaren Heart & Vascular
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York City
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's University Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Southeast
state: Texas
city: Sugarland
country: United States
facility: Houston Methodist Sugarland
state: Texas
city: Norfolk
country: United States
facility: Sentara
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center (CAMC)
state: West Virginia
Study officials:
affiliation: Lancaster General Hospital
name: Meghan Dermody, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott Northwestern Minneapolis Heart Institute Foundation
name: Jeffrey Jim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Marc Schermerhorn, MD
role: PRINCIPAL_INVESTIGATOR
References: