Clinical trial 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carotid Artery Diseases
Keywords: Carotid Artery Stenosis
Transcarotid Artery Revascularization
Carotid Artery Angioplasty
Stenting Procedure
Lead sponsor: InspireMD
Sponsor class: INDUSTRY
Collaborators: name: Washington University School of Medicine
name: TriHealth Inc.
name: NAMSA
First posted: 2024-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study is a prospective, multi-center, single arm pivotal study. The study shall not be blinded prior to, during or following the procedure. Patients undergoing transcarotid artery revascularization will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provide informed consent and shall subsequently be assigned a study ID number.

Enrollment will be a minimum of 50 evaluable pivotal patients. A maximum of 20% of patients will be enrolled at any single site. The total enrollment accounts for an estimate that up to 2 patients will exit the study prior to the 30-day primary endpoint assessment.

An additional roll-in cohort of up to 2 patients per primary physician operator at each study site may also be accrued (maximum of 24 roll-in patients total, assuming one primary physician operator per site).

This study does not duplicate any current knowledge existing today on use of the CGuard Prime™ 80 used in conjunction with the ENROUTE NPS in the United States.

Eligibility criteria: INCLUSION CRITERIA: Candidates for participation in the study must meet all of the following general inclusion criteria.

* 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
* Restenosis from previous carotid endarterectomy (CEA)
* Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31-60 days after CAS
* Abdominal aortic aneurysm surgical repair or Endovascular repair is planned between 31 to 60 days after CAS.

Anatomic conditions:

* Occlusion of the contralateral CCA or ICA.
* Prior radiation treatment to the neck or a radical neck dissection.
* Severe bilateral ICA stenosis requiring treatment.
* Target lesion at or above the level of the jaw (C2) or below the clavicle.
* Severe tandem lesions
* Inability to extend the neck due to cervical disorders.
* Laryngeal palsy or laryngectomy.
* Prior head and neck surgery in the region of the carotid artery.
* Tracheostomy or tracheostoma.
* Spinal immobility of the neck.
* Hostile neck or surgically inaccessible lesion.
* Target vessel and lesion meet all requirements for the CGuard Prime™ 80 stent:
* Target lesion location at the carotid bifurcation and/or proximal internal carotid artery (ICA)
* The diameter at the stent landing zone is between 4.8 mm and 9.0 mm.
* The target lesion length is ≤ 36 mm and can be covered by a single CGuard Prime™ 80 stent.
* Patient must have a 5 cm long disease-free segment of the common carotid artery (CCA) measured from the clavicle to the carotid bifurcation, with a minimum vessel diameter of 6 mm suitable for vascular access, sheath insertion, and vessel clamping.

EXCLUSION CRITERIA: Patients are not eligible for the study if they have any of the following exclusion criteria.

* 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:

  1. Chronic atrial fibrillation.
  2. Episode(s) of paroxysmal atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
  3. 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).
  4. Recently (\<60 days) implanted heart valve (either surgically or endovascularly) as a known source of emboli as confirmed on echocardiogram,
  5. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA 6 months prior to index procedure) greater in severity than the lesion to be treated; cerebral aneurysm \> 5mm; AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
* Patient has a known sensitivity or allergy to nickel or titanium.
* Patient has a sensitivity to contrast media that cannot be adequately pre-treated.
* Patient has a sensitivity to both forms of protocol-acceptable anticoagulation strategies (i.e., both heparin AND Bivalirudin)
* Patient has a sensitivity to an antiplatelet agent AND all protocol acceptable alternative antiplatelet options
* Patient has a known intolerance to statins.
* Patient has a life expectancy of less than 3 years from the date of enrollment as determined by the Wallaert Life Expectancy Scale
* Patient has malignancy, primary or recurrent, and does not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
* Patient has an evolving stroke or intracranial hemorrhage, or a history of previous intracranial hemorrhage or brain surgery within the past 12 months.
* Patient had a recent stroke (≤ 7 days) placing him/her at risk of a hemorrhagic conversion during the index procedure.
* Patient has a history of a major stroke with a neurologic deficit (NIHSS of ≥ 15 or mRS ≥3).
* Patient had a TIA or amaurosis fugax or stroke within 48 hours of the index procedure.
* Female patient who is pregnant or lactating or is planning to become pregnant.
* Dementia or other neurologic condition that is likely to confound the neurologic assessment.
* Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
* Patient has been previously enrolled in this clinical trial.
* Patient is likely to be non-compliant with protocol-required follow up or medication in the opinion of the investigator.
* Patient is currently participating in another clinical trial that has not completed its primary endpoint assessment or that may confound this study results.

Primary outcomes:
measure: Acute device success
timeFrame: From enrollment to end of follow-up at 1 year
measure: Technical success
timeFrame: From enrollment to end of follow-up at 1 year
Secondary outcomes:
measure: Procedural success
timeFrame: From enrollment to 30-day follow-up
measure: Treatment success
timeFrame: From enrollment to 30-day follow-up
measure: Occurence of Hierarchical Death, Stroke or Myocardial Infarction (DSMI) within 30 days of the procedure
timeFrame: From enrollment to 30-day follow-up
measure: Hierarchical Death or Stroke rate within 30 days of the procedure
timeFrame: From enrollment to 30-day follow-up
measure: Rate of death within 30 days of the procedure
timeFrame: From enrollment to 30-day follow-up
measure: Rate of all strokes within 30 days of the procedure
timeFrame: From enrollment to 30-day follow-up
measure: Rate of major stroke within 30 days of the procedure
timeFrame: From enrollment to 30-day follow-up
measure: Rate of minor stroke within 30 days of the procedure
timeFrame: From enrollment to 30-day follow-up
measure: Rate of Myocardial Infarction (MI) within 30 days of the procedure
timeFrame: From enrollment to 30-day follow-up
measure: Rate of stent thrombosis or occlusion within 30 days of the index procedure
timeFrame: From enrollment to 30-day follow-up
measure: Rate of stent thrombosis or occlusion through 1-year of the index procedure
timeFrame: From enrollment to end of follow-up at 1 year
measure: All device-related serious adverse events within 30 days of the procedure
timeFrame: From enrollment to 30-day follow-up
measure: All device-related serious adverse events through 1-year of the procedure
timeFrame: From enrollment to end of follow-up at 1 year
measure: Rate of ipsilateral strokes between 31- and 365-day post index procedure
timeFrame: From time of 30-day follow-up to end of follow-up at 1 year
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Minneapolis
country: United States
facility: Allina
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Great Falls
country: United States
facility: Benefis Health System
state: Montana
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
Study officials:
affiliation: Washington University School of Medicine
name: Patrick J. Geraghty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TriHealth Inc.
name: Patrick E. Muck, MD
role: PRINCIPAL_INVESTIGATOR
References: