Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting (C-Guardians)

InspireMD

Status: Active, not recruiting

Conditions: Carotid Artery Stenosis

Treatments: Device: CGuard Carotid Stent implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04900844

PRO-9017

Details and patient eligibility

About

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 undergoing carotid artery stenting (CAS) to a performance goal developed from published CAS literature.

Enrollment: 317 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.

2. Subject is willing and able to take dual antiplatelet therapy for a minimum of 30 days.

3. Life expectancy ≥ 24 months from the date of the index procedure.

4. Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.

5. Subject has a modified Rankin Score of ≤ 2at the time of informed consent.

6. Subject is diagnosed with carotid artery disease treatable with carotid artery stenting and is considered high risk for carotid endarterectomy (CEA) as evidenced by:

   1. 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

   2. Asymptomatic carotid stenosis ≥ 80%

7. Co-Morbidity High Risk Conditions for CEA, i.e., meets one or more of the following criteria:

   1. Age ≥ 70 (maximum 80 years)
   2. CCS angina class 3-4 or unstable angina
   3. Congestive Heart Failure (CHF) NYHA class III-IV
   4. Left ventricular ejection fraction (LVEF) ≤ 35%
   5. MI ≥ 72 hours and < 6 weeks pre-procedure
   6. Multi-vessel CAD (≥ 2 vessels >70% stenosis) and history of angina
   7. Chronic Obstructive Pulmonary Disease (COPD) with FEV1<50
   8. Permanent contralateral cranial nerve injury/paralysis
   9. Restenosis from previous carotid endarterectomy (CEA)
   10. Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31-60 days after CAS
   11. Abdominal aortic aneurysm repair or peripheral vascular surgery is planned between 31 to 60 days after CAS.

   OR

8. High Anatomical Risk for CEA, i.e., meets one or more of the following criteria:

   1. Occlusion of the contralateral CCA or ICA.
   2. Prior radiation treatment to the neck or a radical neck dissection.
   3. Severe bilateral ICA stenosis requiring treatment.
   4. Target lesion at or above the level of the jaw (C2) or below the clavicle.
   5. Severe tandem lesions
   6. Inability to extend the hear due to cervical disorders.
   7. Laryngeal palsy or laryngectomy.
   8. Prior head and neck surgery in the region of the carotid artery.
   9. Tracheostomy or tracheostoma.
   10. Spinal immobility of the neck.
   11. Hostile neck or surgically inaccessible lesion.

9. Angiographic General Inclusion Criteria, i.e., meets all the following criteria:

10. Target lesion location at the carotid bifurcation and/or proximal internal carotid artery (ICA)

11. 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).

12. Target vessel reference diameter at stent landing zone is 4.8 mm to 9.0 mm.

13. Target lesion length ≤ 36 mm, that can be covered by a single CGuard™ stent.

Exclusion criteria

1. Planned interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
2. Severe vascular anatomy that would preclude safe sheath insertion, deliverability of stent or embolic protection device.
3. Type III or bovine aortic arch.
4. Total occlusion of the target vessel.
5. Presence of "String sign" of the target lesion.
6. In-tandem lesions with >= 50% or >= 80% diameter stenosis for symptomatic or asymptomatic patients, respectively, which cannot be covered by a single CGuard™ stent.
7. History of bleeding diatheses or coagulopathy or inability to accept blood transfusions.
8. Bilateral carotid stenosis requiring treatment on both sides within 30 days prior to or following planned index procedure.
9. Subject is on renal replacement therapy or has Stage 4 or 5 Chronic Kidney Disease (CKD).
10. 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.
11. History of thrombophilia.
12. Known sensitivity or allergy to nitinol, titanium, heparin, aspirin or other anticoagulant/ antiplatelet therapies.
13. Contrast media sensitivity or allergy that cannot be pre-treated.
14. Previous stent placement in the target vessel.
15. Evolving stroke or intracranial hemorrhage, or history of previous intracranial hemorrhage or brain surgery within the past 12 months.
16. Major neurologic deficit with NIHSS of ≥ 15.
17. Dementia or other neurologic condition confounding the neurologic assessment.
18. Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
19. Subject previously enrolled in this clinical trial.
20. Possible / probable non-compliance of subject with protocol required follow up or medication.
21. 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.
22. SARS-CoV2 (COVID-19) active infection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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317 participants in 1 patient group

CGuard group

Experimental group

Description:

Single experimental arm compared vs. objective performace goal

Treatment:

Device: CGuard Carotid Stent implantation