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

Primary Purpose

Carotid Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CGuard Carotid Stent implantation
Sponsored by
InspireMD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring Carotid Stenosis, Stenting, Prospective study, Embolic Protection Device (EPD), Carotid Artery Diseases, Cerebrovascular Disorders, Constriction, Pathologic

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

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.

Sites / Locations

  • University of FloridaRecruiting
  • Oschner HealthRecruiting
  • Ascension, St. John HospitalRecruiting
  • Mercy HospitalRecruiting
  • University of BuffaloRecruiting
  • Stony Brook University HospitalRecruiting
  • Novant HealthRecruiting
  • Cleveland ClinicRecruiting
  • UPMC-PinnacleRecruiting
  • Miriam HospitalRecruiting
  • Prisma Health-UpstateRecruiting
  • Avera Heart HospitalRecruiting
  • Ballad CVA Heart InstituteRecruiting
  • Turkey Creek Medical CenterRecruiting
  • Ascension Seton, Seton Heart InstituteRecruiting
  • Leszek Leic Upper-Silesian Medical Centre of the Silesian Medical UniversityRecruiting
  • John Paul II HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CGuard group

Arm Description

Single experimental arm compared vs. objective performace goal

Outcomes

Primary Outcome Measures

Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure
The primary endpoint is the composite of the following: Incidence of the following Major Adverse Events: Death (allcause mortality), all Stroke, and Myocardial Infarction (DSMI) through 30-days post-index procedure, based on Clinical Events Committee (CEC) adjudication OR Ipsilateral stroke from 31-365 day follow-up, based on Clinical Events Committee (CEC) adjudication.

Secondary Outcome Measures

Incidence of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years
Incidence of the following composite of Major Adverse Events: Death (all-cause mortality), all Stroke, and Myocardial Infarction (DSMI) through discharge, 30-days, 6-months, and 1-,2-,3-year follow-up, based on Clinical Events Committee (CEC) adjudication.
Incidence of particular components of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years
Incidence of each individual component of the Major Adverse Events: Death (all-cause mortality), all Stroke, and Myocardial Infarction (DSMI) through discharge, 30-days, 6-months, and 1-,2-,3-year follow-up, based on Clinical Events Committee (CEC) adjudication.
Incidence of ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
Ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
Incidence of major ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
Major ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
Incidence of In-stent Restenosis (ISR) > 70% in ultrasound evaluation
Incidence of In-stent Restenosis (ISR) > 70%. ISR > 70% is defined as PSV > 300 cm/s associated with stent, or vessel occlusion based on transcervical duplex ultrasound through 1-, 2-, 3-year follow-up. Based on Imaging Core Laboratory assessment.
Incidence of In-stent Restenosis (ISR) > 50% in ultrasound evaluation
Incidence of In-stent Restenosis (ISR) > 50%. ISR > 50% is defined as PSV > 220 cm/s associated with stent, or vessel occlusion based on transcervical duplex ultrasound through 1-, 2-, 3-year follow-up. Based on Imaging Core Laboratory assessment.
Incidence of target lesion revascularization
Incidence of Target Lesion Revascularization (TLR) through 1-,2,3-year follow-up. TLR is defined as clinically driven revascularization procedure of the original treatment site, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase the luminal diameter within the stented lesion or within 5 mm proximal or distal to the index stent.
Composite of Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events
Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events from discharge up to 1-,2- and 3-year follow-up.
Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure for subjects that adhere to antiplatelet pharmacology.
Primary endpoint for subjects that adhere to antiplatelet pharmacology.

Full Information

First Posted
May 20, 2021
Last Updated
June 16, 2022
Sponsor
InspireMD
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1. Study Identification

Unique Protocol Identification Number
NCT04900844
Brief Title
Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
Acronym
C-Guardians
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InspireMD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis
Keywords
Carotid Stenosis, Stenting, Prospective study, Embolic Protection Device (EPD), Carotid Artery Diseases, Cerebrovascular Disorders, Constriction, Pathologic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CGuard group
Arm Type
Experimental
Arm Description
Single experimental arm compared vs. objective performace goal
Intervention Type
Device
Intervention Name(s)
CGuard Carotid Stent implantation
Other Intervention Name(s)
Carotid stenting
Intervention Description
Implantation of CGuard carotid stent in the eligible patients
Primary Outcome Measure Information:
Title
Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure
Description
The primary endpoint is the composite of the following: Incidence of the following Major Adverse Events: Death (allcause mortality), all Stroke, and Myocardial Infarction (DSMI) through 30-days post-index procedure, based on Clinical Events Committee (CEC) adjudication OR Ipsilateral stroke from 31-365 day follow-up, based on Clinical Events Committee (CEC) adjudication.
Time Frame
From index procedure to 1 year follow up
Secondary Outcome Measure Information:
Title
Incidence of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years
Description
Incidence of the following composite of Major Adverse Events: Death (all-cause mortality), all Stroke, and Myocardial Infarction (DSMI) through discharge, 30-days, 6-months, and 1-,2-,3-year follow-up, based on Clinical Events Committee (CEC) adjudication.
Time Frame
From index procedure to 3 years follow up
Title
Incidence of particular components of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years
Description
Incidence of each individual component of the Major Adverse Events: Death (all-cause mortality), all Stroke, and Myocardial Infarction (DSMI) through discharge, 30-days, 6-months, and 1-,2-,3-year follow-up, based on Clinical Events Committee (CEC) adjudication.
Time Frame
From index procedure to 3 years follow up
Title
Incidence of ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
Description
Ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
Time Frame
From index procedure to 3 years follow up
Title
Incidence of major ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
Description
Major ipsilateral stroke through discharge, 30 days, 6 months and 1-, 2-, 3-year follow-up.
Time Frame
From index procedure to 3 years follow up
Title
Incidence of In-stent Restenosis (ISR) > 70% in ultrasound evaluation
Description
Incidence of In-stent Restenosis (ISR) > 70%. ISR > 70% is defined as PSV > 300 cm/s associated with stent, or vessel occlusion based on transcervical duplex ultrasound through 1-, 2-, 3-year follow-up. Based on Imaging Core Laboratory assessment.
Time Frame
At 1-, 2-, 3-year post-index procedure follow-up
Title
Incidence of In-stent Restenosis (ISR) > 50% in ultrasound evaluation
Description
Incidence of In-stent Restenosis (ISR) > 50%. ISR > 50% is defined as PSV > 220 cm/s associated with stent, or vessel occlusion based on transcervical duplex ultrasound through 1-, 2-, 3-year follow-up. Based on Imaging Core Laboratory assessment.
Time Frame
At 1-, 2-, 3-year post-index procedure follow-up
Title
Incidence of target lesion revascularization
Description
Incidence of Target Lesion Revascularization (TLR) through 1-,2,3-year follow-up. TLR is defined as clinically driven revascularization procedure of the original treatment site, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase the luminal diameter within the stented lesion or within 5 mm proximal or distal to the index stent.
Time Frame
At 1-, 2-, 3-year post-index procedure follow-up
Title
Composite of Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events
Description
Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events from discharge up to 1-,2- and 3-year follow-up.
Time Frame
From index procedure to 3 years follow up
Title
Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure for subjects that adhere to antiplatelet pharmacology.
Description
Primary endpoint for subjects that adhere to antiplatelet pharmacology.
Time Frame
From index procedure to 1 year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Brennan
Phone
888-776-6804
Email
christinab@inspiremd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Metzger, MD
Organizational Affiliation
Ballad Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Piotr Musialek, MD DPhil
Organizational Affiliation
John Paul II Hospital, Krakow, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Burton
Email
andrea.burton@jax.ufl.edu
First Name & Middle Initial & Last Name & Degree
Daniel Soffer, MD
Facility Name
Oschner Health
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Jenkins, MD
Email
sjenkins@oschner.org
First Name & Middle Initial & Last Name & Degree
Steve Jenkins, MD
Facility Name
Ascension, St. John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhonda Beauchemin
Email
beauchemin@ascension.org
First Name & Middle Initial & Last Name & Degree
Thomas Davis, MD
Facility Name
Mercy Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Mechem
Email
carol.mechem@mercy.net
First Name & Middle Initial & Last Name & Degree
Anish Thomas, MD
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelby Halm
Email
shalm@ubns.com
First Name & Middle Initial & Last Name & Degree
Adnan Siddiqui, MD
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Madigan
Email
dawn.madigan@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
David Fiorella, MD
Facility Name
Novant Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Perez
Email
crperez@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Donald Heck, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Czich, RN, BSN, CCRP
Email
czichc@ccf.org
First Name & Middle Initial & Last Name & Degree
Sean Lyden, MD
Facility Name
UPMC-Pinnacle
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen Meise, RN, BSN, CCRC
Email
meisegc@upmc.edu
First Name & Middle Initial & Last Name & Degree
William Bachinsky, MD
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Felix
Email
lfelix@lifespan.org
First Name & Middle Initial & Last Name & Degree
Peter Soukas, MD
Facility Name
Prisma Health-Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Blain
Email
diane.blain@prismahealth.org
First Name & Middle Initial & Last Name & Degree
Bruce Gray, DO
Facility Name
Avera Heart Hospital
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Farley, RN
Email
rfarley@ncheart.com
First Name & Middle Initial & Last Name & Degree
Michael Bacharach, MD
Facility Name
Ballad CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josh Lester, LPN, CCRC
Email
joshua.lester@balladhealth.org
First Name & Middle Initial & Last Name & Degree
Chris Metzger, MD
Facility Name
Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constance Bales, RN, CCRC
Email
constance.bales@tennova.com
First Name & Middle Initial & Last Name & Degree
Malcolm Foster, MD
Facility Name
Ascension Seton, Seton Heart Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee Shadrach, MSN
Email
aimee.blake@ascension.org
First Name & Middle Initial & Last Name & Degree
Peter Monteleone, MD
Facility Name
Leszek Leic Upper-Silesian Medical Centre of the Silesian Medical University
City
Katowice
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Kuzmick
Email
wkuczmik@interia.pl
First Name & Middle Initial & Last Name & Degree
Professor Kuzmick
Facility Name
John Paul II Hospital
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Mazurek, MD
Email
mazurekadam@yahoo.pl
First Name & Middle Initial & Last Name & Degree
Piotr Musialek, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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