A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 20, 2024

Primary Completion Date

November 20, 2026

Study Completion Date

November 20, 2027

Conditions
Carotid Artery Diseases
Interventions
DEVICE

CGuard Prime 80cm stent system

This study is single arm looking at the technical success of the CGuard Prime 80cm stent system when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.

Trial Locations (8)

10029

RECRUITING

Mount Sinai Hospital, New York

14642

RECRUITING

University of Rochester, Rochester

45220

RECRUITING

TriHealth, Cincinnati

46202

RECRUITING

Indiana University School of Medicine, Indianapolis

55407

RECRUITING

Allina, Minneapolis

59405

RECRUITING

Benefis Health System, Great Falls

63110

RECRUITING

Washington University School of Medicine, St Louis

95817

RECRUITING

UC Davis Health, Sacramento

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Washington University School of Medicine

OTHER

collaborator

TriHealth Inc.

OTHER

collaborator

NAMSA

OTHER

lead

InspireMD

INDUSTRY

NCT06653387 - A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach | Biotech Hunter | Biotech Hunter