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 (NCT06653387)
A Multicenter, Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System (80cm) When Used in Conjunction With the FDA-cleared ENROUTE Transcarotid Neuroprotection System (NPS) in Patients at High Risk for Adverse Events From Carotid Endarterectomy Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UC Davis Health — Sacramento, California
Age range: 18 Years to 79 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- UC Davis Health — Sacramento, California
- Indiana University School of Medicine — Indianapolis, Indiana
- Allina — Minneapolis, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- Benefis Health System — Great Falls, Montana
- Mount Sinai Hospital — New York, New York
- University of Rochester — Rochester, New York
- TriHealth — Cincinnati, Ohio
📞 Contact the Study Coordinator
Phone: (888) 776-6804
Email: inspiremd_cguardians_ii_Comms@namsa.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Carotid Artery Diseases
- Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques — Boston, Massachusetts
- The CREST-2 Registry — Baltimore, Maryland
- Intervascular Post-Market Clinical Follow-Up (PMCF) Registry — Hershey, Pennsylvania
- Assessing Neurocognition After Cerebrovascular Intervention — San Diego, California
Explore by condition: All Carotid Artery Diseases clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.