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 | Recruiting DMC FDA Device

• 1 other identifier: CGUARDIANS II
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Carotid Artery Diseases

Keywords

Carotid Artery Stenosis; Transcarotid Artery Revascularization; Carotid Artery Angioplasty; Stenting Procedure

Outcome Measures

Primary Outcomes (2)

• Acute device success

  Successful insertion of the delivery system, successful deployment of the CGuard Prime™ 80 stent, and successful retraction of the delivery system when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.

  From enrollment to end of follow-up at 1 year

• Technical success

  Technical Success Rate is defined as the number of patients with at least one CGuard Prime™ 80 device successfully delivered and deployed with final residual diameter stenosis \< 30% following final post-balloon dilatation (if performed) divided by the total number of patients where CGuard Prime™ 80 device deployment was attempted when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.

  From enrollment to end of follow-up at 1 year

Secondary Outcomes (14)

• Procedural success

  From enrollment to 30-day follow-up

• Treatment success

  From enrollment to 30-day follow-up

• Occurence of Hierarchical Death, Stroke or Myocardial Infarction (DSMI) within 30 days of the procedure

  From enrollment to 30-day follow-up

• Hierarchical Death or Stroke rate within 30 days of the procedure

  From enrollment to 30-day follow-up

• Rate of death within 30 days of the procedure

  From enrollment to 30-day follow-up

Study Arms (1)

CGuard Prime 80cm stent system with ENROUTE NPS

EXPERIMENTAL

Device: CGuard Prime 80cm stent system

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.

CGuard Prime 80cm stent system with ENROUTE NPS

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years and \< 80 years of age.
• Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
• Patient is diagnosed with carotid artery disease treatable with a Carotid Artery Stent via a Transcarotid Artery Revascularization approach and is either symptomatic or asymptomatic, defined as:
• Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax, transient ischemia attack (TIA) or stroke within the last 6 months ipsilateral to the side of the stenosis Or
• Asymptomatic carotid stenosis ≥ 80%
• High Risk condition for CEA: at least one, as shown below:
• Comorbid conditions:
• Age ≥ 70 (maximum 80 years)
• CCS angina class 3-4 or unstable angina
• Congestive Heart Failure (CHF) NYHA class III-IV
• Left ventricular ejection fraction (LVEF) ≤ 35%
• MI ≥ 72 hours and \< 6 weeks pre-procedure
• Multi-vessel CAD (≥ 2 vessels \>70% stenosis) and history of angina
• Chronic Obstructive Pulmonary Disease (COPD) with FEV1\<50
• Permanent contralateral cranial nerve injury/paralysis

You may not qualify if:

• Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
• Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure.
• Vascular anatomy that would preclude safe sheath insertion or deliverability of stent
• Patient had a previously placed stent in the ipsilateral ICA or CCA.
• Total occlusion or presence of a "string sign" of the ipsilateral ICA or CCA.
• Presence of a filling defect of the target lesion.
• Tandem lesions, which cannot be covered by a single CGuard Prime™ stent.
• Patient has a stenosis of the innominate artery or proximal CCA requiring revascularization
• Patient has an open neck stoma.
• Patient has a history of bleeding diatheses or coagulopathy.
• Patient has hypercoagulable state.
• Patient has an alternative source of cerebral embolus, including but not limited to:
• Chronic atrial fibrillation.
• Episode(s) of paroxysmal atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
• Knowledge of cardiac sources of embolus (e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).

Sponsors & Collaborators

• InspireMD: lead
• Washington University School of Medicine: collaborator
• TriHealth Inc.: collaborator
• NAMSA: collaborator

Study Sites (8)

UC Davis Health

Sacramento, California, 95817, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Allina

Minneapolis, Minnesota, 55407, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Benefis Health System

Great Falls, Montana, 59405, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

TriHealth

Cincinnati, Ohio, 45220, United States

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases

Study Officials

• Patrick J. Geraghty, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Patrick E. Muck, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

InspireMD/NAMSA

CONTACT

1-888-776-6804; inspiremd_cguardians_ii_Comms@namsa.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (8)