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

Part of paid clinical trials in Sacramento, California.

Sponsor
InspireMD
Study ID
NCT06653387
Status
Recruiting
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Conditions

  • Carotid Artery Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • CGuard Prime 80cm stent system — DEVICE
    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.

Study Details

The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.

Key Dates

Start date
Nov 20, 2024
Status verified
May 2025
Primary completion
Nov 20, 2026
Completion
Nov 20, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CGuard Prime 80cm stent system with ENROUTE NPS

Primary Outcome Measure

Acute device success [ Time Frame: From enrollment to end of follow-up at 1 year ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
UC Davis HealthSacramentoCalifornia95817
Misty Humphries, MD
Indiana University School of MedicineIndianapolisIndiana46202
Raghu Motaganahalli, MD
AllinaMinneapolisMinnesota55407
Jeffrey Jim, MD
Washington University School of MedicineSt LouisMissouri63110
Patrick J Geraghty, MD
Benefis Health SystemGreat FallsMontana59405
Dimitrios Koudoumas, MD
Mount Sinai HospitalNew YorkNew York10029
Peter Faries, MD
University of RochesterRochesterNew York14642
Michael Stoner, MD
TriHealthCincinnatiOhio45220
Patrick Muck, MD

Find similar trials in Sacramento, CA

By research site
UC Davis Health· Sacramento, CAIndiana University School of Medicine· Indianapolis, INAllina· Minneapolis, MNWashington University School of Medicine· St Louis, MOBenefis Health System· Great Falls, MTMount Sinai Hospital· New York, NY

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