Carotid Artery Diseases
Conditions
Keywords
Carotid Artery Stenosis, Transcarotid Artery Revascularization, Carotid Artery Angioplasty, Stenting Procedure
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.
Interventions
DEVICECGuard 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.
Sponsors
Washington University School of Medicine
TriHealth Inc.
NAMSA
InspireMD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute device success | From enrollment to end of follow-up at 1 year | 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. |
| Technical success | From enrollment to end of follow-up at 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | From enrollment to 30-day follow-up | Acute device success for CGuard PrimeTM 80 Delivery System and Stent without experiencing death, stroke or MI through 30-day post-procedure when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure. |
| Treatment success | From enrollment to 30-day follow-up | Treatment Success Rate is defined as the number of patients who meet CGuard Prime™ 80 Technical Success Rate without experiencing death, stroke or MI through 30-day post-procedure, 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. |
| 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 | — |
| Rate of all strokes within 30 days of the procedure | From enrollment to 30-day follow-up | — |
| Rate of minor stroke within 30 days of the procedure | From enrollment to 30-day follow-up | — |
| Rate of stent thrombosis or occlusion within 30 days of the index procedure | From enrollment to 30-day follow-up | — |
| Rate of stent thrombosis or occlusion through 1-year of the index procedure | From enrollment to end of follow-up at 1 year | — |
| All device-related serious adverse events within 30 days of the procedure | From enrollment to 30-day follow-up | — |
| All device-related serious adverse events through 1-year of the procedure | From enrollment to end of follow-up at 1 year | — |
| Rate of ipsilateral strokes between 31- and 365-day post index procedure | From time of 30-day follow-up to end of follow-up at 1 year | — |
| Rate of Myocardial Infarction (MI) within 30 days of the procedure | From enrollment to 30-day follow-up | — |
| Rate of major stroke within 30 days of the procedure | From enrollment to 30-day follow-up | — |
Countries
United States
Contacts
Primary ContactInspireMD/NAMSA
Outcome results
None listed