Clinical trial NCT04900844: Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
Official title: A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard™ Carotid Stent System When Used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carotid Artery Stenosis
Keywords: Carotid Stenosis
Stenting
Prospective study
Embolic Protection Device (EPD)
Carotid Artery Diseases
Cerebrovascular Disorders
Constriction, Pathologic
Lead sponsor: InspireMD
Sponsor class: INDUSTRY
First posted: 2021-05-25
Enrollment: 317
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm trial, where the primary endpoint will be compared to a performance goal. The null hypothesis will be rejected (i.e. performance goal is met) if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is \< 11.6% and the p-value is less than 0.025.
Primary purpose: TREATMENT

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.


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.

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

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.

Primary outcomes:
measure: Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure
timeFrame: From index procedure to 1 year follow up
Secondary outcomes:
measure: Incidence of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years
timeFrame: From index procedure to 3 years follow up
measure: Incidence of particular components of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years
timeFrame: From index procedure to 3 years follow up
measure: Incidence of ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
timeFrame: From index procedure to 3 years follow up
measure: Incidence of major ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
timeFrame: From index procedure to 3 years follow up
measure: Incidence of In-stent Restenosis (ISR) > 70% in ultrasound evaluation
timeFrame: At 1-, 2-, 3-year post-index procedure follow-up
measure: Incidence of In-stent Restenosis (ISR) > 50% in ultrasound evaluation
timeFrame: At 1-, 2-, 3-year post-index procedure follow-up
measure: Incidence of target lesion revascularization
timeFrame: At 1-, 2-, 3-year post-index procedure follow-up
measure: Composite of Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events
timeFrame: From index procedure to 3 years follow up
measure: Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure for subjects that adhere to antiplatelet pharmacology.
timeFrame: From index procedure to 1 year follow up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: New Orleans
country: United States
facility: Oschner Health
state: Louisiana
city: Detroit
country: United States
facility: Ascension, St. John Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Novant Health
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Harrisburg
country: United States
facility: UPMC-Pinnacle
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Prisma Health-Upstate
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Heart Hospital
state: South Dakota
city: Kingsport
country: United States
facility: Ballad CVA Heart Institute
state: Tennessee
city: Knoxville
country: United States
facility: Turkey Creek Medical Center
state: Tennessee
city: Austin
country: United States
facility: Ascension Seton, Seton Heart Institute
state: Texas
city: Katowice
country: Poland
facility: Leszek Leic Upper-Silesian Medical Centre of the Silesian Medical University
city: Kraków
country: Poland
facility: John Paul II Hospital
Study officials:
affiliation: Ballad Health
name: Chris Metzger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: John Paul II Hospital, Krakow, Poland
name: Piotr Musialek, MD DPhil
role: PRINCIPAL_INVESTIGATOR
References: