Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System

NCT04201132 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CSP1400
• Study Type: interventional
• Target: 305
• Locations: 6 countries
• Sites: 38

Brief Summary

A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).

Conditions

Carotid Artery Stenosis; Carotid Artery Diseases; Carotid Stenosis

Outcome Measures

Primary Outcomes (2)

• MAE

  Death, all stroke and myocardial infarction (MI)

  30 days

• Ipsilateral Stroke

  Ipsilateral hemiparesis

  12 months

Secondary Outcomes (8)

• Technical success

  Day of procedure

• Procedure success

  Day of procedure

• TLR

  12 months

• In-Stent Restenosis (ISR)

  12 months, 24 months, 36 months

• Major stroke

  30 days

Study Arms (1)

Carotid artery stenting

EXPERIMENTAL

Carotid artery stenting procedure with Neuroguard IEP System

Device: Carotid artery stenting with Neuroguard IEP System

Interventions

Carotid artery stenting with Neuroguard IEP System DEVICE

Carotid artery stenting (treatment) with the Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection

Carotid artery stenting

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 20 years and ≤ 80.
• Patient is willing and capable of complying with all study protocol requirements, including the specified follow-up visits and can be contacted by telephone.
• Patient or his/her authorized legal representative must sign a written informed consent form that has been approved by the local governing Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.
• Patient is diagnosed with carotid artery stenosis treatable with carotid artery stenting and is considered a high operative risk for CEA.
• Patient is diagnosed with either:
• Symptomatic carotid stenosis ≥ 50% as determined by angiography using NASCET methodology. Symptomatic is defined as ipsilateral transient monocular blindness: amaurosis fugax; ipsilateral carotid transient ischemic attack (TIA), with neurologic symptoms persisting less than 24 hours; or ipsilateral non-disabling stroke within 180 days of the procedure; or
• Asymptomatic carotid stenosis ≥ 80% as determined by angiography using NASCET methodology.
• Patient has a modified Rankin Scale score of ≤ 2 at the time of informed consent.
• Females of child-bearing potential have a negative pregnancy test within 24 hours of the index procedure.
• Patient is willing and able to take dual antiplatelet therapy for a minimum of 30 days following the index procedure.
• Target lesion located at the carotid bifurcation and/or proximal internal carotid artery (ICA).
• Single de novo or restenotic (post carotid endarterectomy (CEA)) target lesion or severe tandem lesions that can be covered by a single Neuroguard stent.
• Target lesion length is ≤ 20 mm (for 30 mm stents) or is ≤ 30 mm (for 40 mm stents).
• Index vessel diameter (segment covered by the mid-portion of the stent) between 4.0 mm and 6.0 mm at the site of the target lesion.
• Distal vessel diameter at the site of filter deployment is between 4.0 mm to 7.0 mm.

You may not qualify if:

• Life expectancy of less than one year, cancer with metastatic spread, undergoing active chemotherapy treatment, or currently requiring an organ transplantation.
• An evolving acute stroke.
• Anticipated or potential sources of emboli including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \< 1.0 cm2), endocarditis, moderate to severe mitral stenosis, known previously symptomatic PFO, left atrial thrombus, any intracardiac mass or DVT or PE treated within the past 12 months.
• History of paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation
• History of chronic atrial flutter or atrial fibrillation.
• Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents within 14 days of the index procedure.
• Acute febrile illness (temperature \> 100.4F or 38C) or active infection.
• Subjects with presumptive or confirmed SARS-CoV-2/COVID-19 infection.
• A SARS-CoV-2/COVID-19 test shall be performed 72 hours prior to the index procedure for all subjects
• Note: If a subject has confirmed SARS-CoV-2/COVID-19 infection (SARSCoV-2/COVID-19+), eligibility may be re-established 21 days following diagnosis if infection is asymptomatic and 21 days following resolution of symptoms if infection is symptomatic.
• Acute myocardial infarction \< 14 days prior to index procedure.
• Any major surgical procedure (i.e. intraabdominal or intrathoracic surgery or any surgery / interventional procedure involving cardiac or vascular system) 30 days prior to or following the index procedure.
• History of major disabling stroke with substantial residual disability (modified Rankin score ≥ 3)
• Known severe carotid stenosis or complete occlusion contralateral to the target lesion requiring treatment within 30 days of the index procedure.
• Other neurological deficit not due to stroke that may confound the neurological assessments.

Sponsors & Collaborators

• Contego Medical, Inc.: lead
• Yale Cardiovascular Research Group: collaborator
• Advance Research Associates: collaborator
• CardioMed Device Consultants, LLC: collaborator
• Iqvia Pty Ltd: collaborator
• Medidata Solutions: collaborator

Study Sites (38)

Huntsville Hospital

Huntsville, Alabama, 35801, United States

Location

St. Helena Hospital

St. Helena, California, 94574, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

Lyerly Baptist Neurosurgery

Jacksonville, Florida, 32207, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Lexington

Lexington, Kentucky, 40503, United States

Location

Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

White Oak Medical Center

Silver Spring, Maryland, 20904, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University at Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Location

Mt. Sinai

New York, New York, 10029, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

North Carolina Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

St. Vincent Hospital

Erie, Pennsylvania, 16502, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16507, United States

Location

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, 17043, United States

Location

Lankenau Institute

Wynnewood, Pennsylvania, 19096, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Prisma Health Midlands

Columbia, South Carolina, 29203, United States

Location

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Location

Monument Health - Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

North Central Heart Institute

Sioux Falls, South Dakota, 57108, United States

Location

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Ballad Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 27934, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Acibadem City Clinic University Hospital

Sofia, 1407, Bulgaria

Location

University Herzzentrum Bad Krozingen

Bad Krozingen, 78189, Germany

Location

Sankt Gertrauden-Krankenhaus GmbH

Berlin, 10713, Germany

Location

Cardiovascular Centre Frankfurt

Frankfurt, Germany

Location

Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

Hamburg, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Elblandklinikum Radebeul

Radebeul, 01445, Germany

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

University Clinic of Cardiology Skopje

Skopje, 1000, North Macedonia

Location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Gray WA, Metzger DC, Zidar J, Kedev S, Petrov I, Soukas P, Levy E, Bachinsky W, Bacharach JM, Montorsi P, Novack V, Lansky A, Langhoff R. The PERFORMANCE II Trial: A Prospective Multicenter Investigation of a Novel Carotid Stent System. JACC Cardiovasc Interv. 2025 Feb 10;18(3):367-376. doi: 10.1016/j.jcin.2024.10.031. Epub 2025 Jan 8.

  PMID: 39797836 DERIVED

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• William A Gray, MD

  Main Line Health

  PRINCIPAL INVESTIGATOR

• Ralf Langhoff, MD

  Sankt Gertrauden Krankenhaus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: June 12, 2020
• Primary Completion: October 31, 2023
• Study Completion: December 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); NO (1); SL (1); BU (1); IT (1); US (28)