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

Not Applicable

Active, not recruiting

• Conditions: Carotid Artery Diseases; Carotid Stenosis; Carotid Artery Stenosis
• Interventions: Device: Carotid artery stenting with Neuroguard IEP System

• Registration Number: NCT04201132
• Lead Sponsor: Contego Medical, Inc.

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).

Detailed Description

The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. Eligible patients must be between 20 and 80 years of age and diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with ≥50% stenosis if symptomatic), or, ≥80% stenosis if asymptomatic (both defined by angiography using NASCET methodology). Symptomatic patients are defined as having stroke or TIA ipsilateral to the carotid lesion within 180 days of the procedure within the hemisphere supplied by the target vessel. Enrolled subjects will be followed at 30 days, 6 months, 12 months, 24 months and 36 months.

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-17
• Study Start: 2020-06-12
• Primary Completion: 2023-10-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

Not provided

Exclusion Criteria

1. Life expectancy of less than one year, cancer with metastatic spread, undergoing active chemotherapy treatment, or currently requiring an organ transplantation.

2. An evolving acute stroke.

3. 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.

4. History of paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation

5. History of chronic atrial flutter or atrial fibrillation.

6. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents within 14 days of the index procedure.

7. Acute febrile illness (temperature > 100.4F or 38C) or active infection.

8. 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.

9. Acute myocardial infarction < 14 days prior to index procedure.

10. 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.

11. History of major disabling stroke with substantial residual disability (modified Rankin score ≥ 3)

12. Known severe carotid stenosis or complete occlusion contralateral to the target lesion requiring treatment within 30 days of the index procedure.

13. Other neurological deficit not due to stroke that may confound the neurological assessments.

14. Dementia considered other than mild.

15. Known hypersensitivity to nitinol or its components (e.g. nickel, titanium).

16. History of intracranial hemorrhage within 90 days prior to the index procedure.

17. History of GI bleed within 30 days prior to the index procedure

18. Chronic renal insufficiency (serum creatinine ≥ 2.5 ml/dL or estimated GFR < 30 cc/min)

19. Any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe (e.g., severe hepatic impairment, malignant hypertension, morbid obesity).

20. Known hypersensitivity to contrast media that cannot be adequately premedicated.

21. Hemoglobin (Hgb) < 8 gm/dL, platelet count < 100,000, INR > 1.5 (irreversible), or heparin-induced thrombocytopenia.

22. History or current indication of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clot time at ≥ 250 seconds.

23. Contraindication to standard of care study medications, including antiplatelet therapy or aspirin.

24. Currently enrolled in another interventional device or drug study that has not yet reached the primary endpoint.

25. Potential for subject non-compliance with protocol-required follow up or anti platelet medication in the opinion of the investigator.

Angiographic Exclusion Criteria

1. Total occlusion of the target carotid artery.
2. Previously placed stent in the ipsilateral carotid artery.
3. Severe calcification or vascular tortuosity of the target vessel that may preclude the safe introduction of the sheath, guiding catheter, distal filter, Neuroguard stent or Neuroguard filter. Excessive circumferential calcification of the target lesion is defined as >3 mm of thickness of calcification seen in orthogonal views on fluoroscopy. Severe vascular tortuosity is defined as 2 or more bends of 90 degrees or more within 4 cm of the target lesion.
4. Qualitative characteristics of stenosis and stenosis-length of carotid bifurcation (common carotid) and/or ipsilateral external carotid artery, that preclude the safe introduction of the sheath.
5. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery (CCA) that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement.
6. Angiographic evidence of a mobile filling defect or fresh thrombus in the target carotid artery.
7. Presence of "string sign" of the target lesion (a sub-totally occluded, long segment of the true lumen of the artery with markedly reduced contrast flow).
8. Non-atherosclerotic carotid stenosis (e.g. dissection, fibromuscular dysplasia)
9. Proximal/ostial CCA, innominate stenosis, or intracranial stenosis located distal to the target stenosis that is more severe that target stenosis.
10. Patient in whom percutaneous vascular access is not possible, including severe tortuosity or stenosis that requires additional endovascular procedures to facilitate aortic arch access or that prevents safe and expeditious access.
11. Patient with intracranial pathology that, in the opinion of the investigator, makes the patient inappropriate for study participation (e.g., arteriovenous malformations, brain tumor, microangiopathy or large vessel cerebral vascular disease, etc) or that would confound the neurological evaluation.
12. Known mobile plaque or thrombus in the aortic arch.
13. Type III aortic arch.
14. Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis, tortuosity or angulation of the aortic arch or origin of the innominate or common carotid arteries that would preclude or make difficult safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carotid artery stenting	Carotid artery stenting with Neuroguard IEP System	Carotid artery stenting procedure with Neuroguard IEP System

Primary Outcome Measures

Name	Time	Method
MAE	30 days	Death, all stroke and myocardial infarction (MI)
Ipsilateral Stroke	12 months	Ipsilateral hemiparesis

Secondary Outcome Measures

Name	Time	Method
TLR	12 months	Target Lesion Revascularization
Neurological death	12 months	Death after a stroke that is either a direct consequence of the stroke or a complication of the stroke
In-Stent Restenosis (ISR)	12 months, 24 months, 36 months	Restenosis of stented segment
Procedure success	Day of procedure	Successful stent implantation with \<50% residual stenosis
Minor stroke	30 days	New focal ischemic neurological deficit of abrupt onset lasting \> 24 hours and increases NIHSS by less than or equal to 3 points at 7 days
Major stroke	30 days	New focal ischemic neurological deficit of abrupt onset which is present after 7 days and results in greater than or equal to 4 point increase in NIHSS compared to baseline.
Transient Ischemic Attack (TIA)	30 days	Focal ischemic neurological deficit of abrupt onset and of presumed vascular etiology that resolves completely within 24 hours of onset
Technical success	Day of procedure	Successful stent deployment, successful filter deployment and retrieval, successful stent post-dilation and successful delivery system retrieval

Trial Locations

Locations (38)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Cardiovascular Centre Frankfurt; 🇩🇪 Frankfurt, Germany

Centro Cardiologico Monzino; 🇮🇹 Milan, Italy

Turkey Creek Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Lyerly Baptist Neurosurgery; 🇺🇸 Jacksonville, Florida, United States

Terrebonne General Medical Center; 🇺🇸 Houma, Louisiana, United States

White Oak Medical Center; 🇺🇸 Silver Spring, Maryland, United States

Sankt Gertrauden-Krankenhaus GmbH; 🇩🇪 Berlin, Germany

University Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Prisma Health Midlands; 🇺🇸 Columbia, South Carolina, United States

Manatee Memorial Hospital; 🇺🇸 Bradenton, Florida, United States

Prisma Health Upstate; 🇺🇸 Greenville, South Carolina, United States

Ballad Wellmont Holston Valley Medical Center; 🇺🇸 Kingsport, Tennessee, United States

Acibadem City Clinic University Hospital; 🇧🇬 Sofia, Bulgaria

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

North Central Heart Institute; 🇺🇸 Sioux Falls, South Dakota, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Monument Health - Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

Stern Cardiovascular Foundation; 🇺🇸 Germantown, Tennessee, United States

University Clinic of Cardiology Skopje; 🇲🇰 Skopje, North Macedonia

Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH; 🇩🇪 Hamburg, Germany

Texas Heart Institute; 🇺🇸 Houston, Texas, United States

St. Helena Hospital; 🇺🇸 Saint Helena, California, United States

Huntsville Hospital; 🇺🇸 Huntsville, Alabama, United States

University of Iowa Hospital and Clinics; 🇺🇸 Iowa City, Iowa, United States

Mt. Sinai; 🇺🇸 New York, New York, United States

North Carolina Heart and Vascular Research; 🇺🇸 Raleigh, North Carolina, United States

University at Buffalo Neurosurgery; 🇺🇸 Buffalo, New York, United States

St. Vincent Hospital; 🇺🇸 Erie, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute; 🇺🇸 Harrisburg, Pennsylvania, United States

UPMC Hamot; 🇺🇸 Erie, Pennsylvania, United States

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Lankenau Institute; 🇺🇸 Wynnewood, Pennsylvania, United States

Elblandklinikum Radebeul; 🇩🇪 Radebeul, Germany

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States

University of Lexington; 🇺🇸 Lexington, Kentucky, United States