Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
Lead Sponsor:
InspireMD
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
The objective of this pivotal study is to evaluate the safety and efficacy of the CGuard™ Carotid Stent System in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients unde...
Eligibility Criteria
Inclusion
- Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
- Subject is willing and able to take dual antiplatelet therapy for a minimum of 30 days.
- Life expectancy ≥ 24 months from the date of the index procedure.
- Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
- Subject has a modified Rankin Score of ≤ 2at the time of informed consent.
- Subject is diagnosed with carotid artery disease treatable with carotid artery stenting and is considered high risk for carotid endarterectomy (CEA) as evidenced by:
- 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%
- Co-Morbidity High Risk Conditions for CEA, i.e., meets one or more of the following criteria:
- 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 repair or peripheral vascular surgery is planned between 31 to 60 days after CAS.
- OR
- High Anatomical Risk for CEA, i.e., meets one or more of the following criteria:
- 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 hear 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.
- 10\. Angiographic General Inclusion Criteria, i.e., meets all the following criteria:
- Target lesion location at the carotid bifurcation and/or proximal internal carotid artery (ICA)
- Vessel distal to target lesion can accommodate a distal embolic protection device (EPD), and EPD is compatible with CGuard™ device (refer to CGuard™ System IFU for specific EPDs).
- Target vessel reference diameter at stent landing zone is 4.8 mm to 9.0 mm.
- Target lesion length ≤ 36 mm, that can be covered by a single CGuard™ stent.
Exclusion
- Planned interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
- Severe vascular anatomy that would preclude safe sheath insertion, deliverability of stent or embolic protection device.
- Type III or bovine aortic arch.
- Total occlusion of the target vessel.
- Presence of "String sign" of the target lesion.
- In-tandem lesions with \>= 50% or \>= 80% diameter stenosis for symptomatic or asymptomatic patients, respectively, which cannot be covered by a single CGuard™ stent.
- History of bleeding diatheses or coagulopathy or inability to accept blood transfusions.
- Bilateral carotid stenosis requiring treatment on both sides within 30 days prior to or following planned index procedure.
- Subject is on renal replacement therapy or has Stage 4 or 5 Chronic Kidney Disease (CKD).
- Known reason for potential stroke other than carotid artery stenosis, including history of atrial fibrillation or other sources of thromboemboli within the past 12 months.
- History of thrombophilia.
- Known sensitivity or allergy to nitinol, titanium, heparin, aspirin or other anticoagulant/ antiplatelet therapies.
- Contrast media sensitivity or allergy that cannot be pre-treated.
- Previous stent placement in the target vessel.
- Evolving stroke or intracranial hemorrhage, or history of previous intracranial hemorrhage or brain surgery within the past 12 months.
- Major neurologic deficit with NIHSS of ≥ 15.
- Dementia or other neurologic condition confounding the neurologic assessment.
- Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
- Subject previously enrolled in this clinical trial.
- Possible / probable non-compliance of subject with protocol required follow up or medication.
- Subject is currently participating in another clinical trial that has not completed its primary endpoint assessment or would confound this C-GUARDIANS Pivotal IDE Clinical Study.
- SARS-CoV2 (COVID-19) active infection.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT04900844
Start Date
July 1 2021
End Date
October 1 2025
Last Update
April 4 2025
Active Locations (18)
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1
University of Florida
Jacksonville, Florida, United States, 32209
2
Oschner Health
New Orleans, Louisiana, United States, 70121
3
Ascension, St. John Hospital
Detroit, Michigan, United States, 48236
4
Mercy Hospital
St Louis, Missouri, United States, 63141