Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting

NCT ID: NCT04900844

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 317 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-10-01

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

Conditions

Carotid Artery Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CGuard group

Single experimental arm compared vs. objective performace goal

Group Type: EXPERIMENTAL

CGuard Carotid Stent implantation

Intervention Type: DEVICE

Implantation of CGuard carotid stent in the eligible patients

Interventions

CGuard Carotid Stent implantation

Implantation of CGuard carotid stent in the eligible patients

Intervention Type: DEVICE

Other Intervention Names

Carotid stenting

Eligibility Criteria

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.

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

2. 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).

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

4. 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InspireMD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Metzger, MD

Role: PRINCIPAL_INVESTIGATOR

Ballad Health

Piotr Musialek, MD DPhil

Role: PRINCIPAL_INVESTIGATOR

John Paul II Hospital, Krakow, Poland

Locations

University of Florida

Jacksonville, Florida, United States

Oschner Health

New Orleans, Louisiana, United States

Ascension, St. John Hospital

Detroit, Michigan, United States

Mercy Hospital

St Louis, Missouri, United States

University of Buffalo

Buffalo, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Novant Health

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

UPMC-Pinnacle

Harrisburg, Pennsylvania, United States

Miriam Hospital

Providence, Rhode Island, United States

Prisma Health-Upstate

Greenville, South Carolina, United States

Avera Heart Hospital

Sioux Falls, South Dakota, United States

Ballad CVA Heart Institute

Kingsport, Tennessee, United States

Turkey Creek Medical Center

Knoxville, Tennessee, United States

Ascension Seton, Seton Heart Institute

Austin, Texas, United States

Leszek Leic Upper-Silesian Medical Centre of the Silesian Medical University

Katowice, , Poland

John Paul II Hospital

Krakow, , Poland

Countries

United States; Poland

Other Identifiers

PRO-9017

Identifier Type: -

Identifier Source: org_study_id