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Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04201132
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Contego Medical, Inc.

Tracking Information
First Submitted Date  ICMJE December 13, 2019
First Posted Date  ICMJE December 17, 2019
Last Update Posted Date May 27, 2022
Actual Study Start Date  ICMJE June 12, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Rate of stroke, death and myocardial infarction (MI) [ Time Frame: 30 days ]
  • Rate of ipsilateral stroke [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2019)
  • All stroke, death and myocardial infarction (MI) [ Time Frame: 30 days ]
  • Ipsilateral stroke [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2019)
  • Technical success [ Time Frame: Day of procedure ]
    Successful stent deployment, successful filter deployment and retrieval, successful stent post-dilation and successful delivery system retrieval
  • Procedure success [ Time Frame: Day of procedure ]
    Successful stent implantation with <50% residual stenosis
  • Target lesion revascularization (TLR) [ Time Frame: 12 months ]
  • In-stent restenosis (ISR) [ Time Frame: 12 months, 24 months, 36 months ]
  • Major stroke [ Time Frame: 30 days ]
  • Minor stroke [ Time Frame: 30 days ]
  • Transient ischemic attack (TIA) [ Time Frame: 30 days ]
  • Neurological death [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System
Official Title  ICMJE Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1 Delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter and a Novel Carotid Stent II
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). 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 between 20 and 80 years of age have been 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carotid Artery Stenosis
  • Carotid Artery Diseases
  • Carotid Stenosis
Intervention  ICMJE Device: Carotid artery stenting with Neuroguard IEP System
Carotid artery stenting (treatment) with the Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection
Study Arms  ICMJE Experimental: Carotid artery stenting
Carotid artery stenting procedure with Neuroguard IEP System
Intervention: Device: Carotid artery stenting with Neuroguard IEP System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2019)
305
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2024
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

General Inclusion Criteria

  1. Male and non-pregnant female subjects whose age is ≥ 20 years and ≤ 80.
  2. Patient is willing and capable of complying with all study protocol requirements, including the specified follow-up visits and can be contacted by telephone.
  3. 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.
  4. Patient is diagnosed with carotid artery stenosis treatable with carotid artery stenting and is considered a high operative risk for CEA.
  5. Patient is diagnosed with either:

    1. 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
    2. Asymptomatic carotid stenosis ≥ 80% as determined by angiography using NASCET methodology.
  6. Patient has a modified Rankin Scale score of ≤ 2 at the time of informed consent.
  7. Patient is willing and able to take dual antiplatelet therapy for a minimum of 30 days.

Angiographic Inclusion Criteria

  1. Target lesion located at the carotid bifurcation and/or proximal internal carotid artery (ICA).
  2. Single de novo or restenotic (post carotid endarterectomy (CEA)) target lesion or severe tandem lesions that can be covered by a single Neuroguard stent.
  3. Target lesion length is ≤ 20 mm (for 30 mm stents) or is ≤ 30 mm (for 40 mm stents)
  4. 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.
  5. Distal vessel diameter at the site of filter deployment is between 4.0 mm to 7.0 mm.
  6. Distal common carotid artery diameter (segment covered by proximal portion of the stent) between 4.0 mm and 8.0 mm
  7. Sufficient landing zone exists in the cervical internal carotid artery distal to the target lesion to allow for the safe and successful deployment of both the primary embolic protection filter and the Neuroguard integrated filter.

High Risk for CEA Conditions For inclusion in the study, a patient must meet at least one significant anatomic or comorbid high risk conditions listed below. Patients at high risk for CEA are defined as having significant comorbidities and/or anatomic risk factors and would be poor candidates for carotid endarterectomy (CEA) in the opinion of a physician.

High Anatomic Risk for CEA Conditions

  1. Target lesion at or above C2 (level of jaw) or below the clavicle.
  2. Inability to extend the head due to cervical arthritis or other cervical disorders.
  3. History of radiation treatment to the neck or radical neck dissection
  4. Prior head and neck surgery in the region of the carotid artery.
  5. Spinal immobility of the neck.
  6. Tracheostomy or tracheostoma.
  7. Hostile neck or surgically inaccessible lesion
  8. Laryngeal palsy or laryngectomy.
  9. Severe tandem lesions (total length must be ≤ 30 mm and must be covered with one stent).
  10. Occlusion of the contralateral CCA or ICA.
  11. Severe bilateral ICA stenosis requiring treatment.

High Co-morbid Risk Conditions for CEA

  1. Patient is ≥ 70 years of age (maximum 80 years) at the time of enrollment.
  2. NYHA Class III or IV congestive heart failure (CHF)
  3. Chronic obstructive pulmonary disease (COPD) with FEV1 < 50
  4. Left ventricular ejection fraction (LVEF) ≤ 35%
  5. Unstable angina
  6. History of recent MI (Between 14 days and 6 weeks prior to index the procedure)
  7. Coronary artery disease with two or more vessels with ≥ 70% stenosis
  8. Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31 - 60 days after CAS procedure
  9. Peripheral vascular surgery or abdominal aortic aneurysm repair is required between 31 - 60 days following CAS procedure
  10. Contralateral laryngeal nerve paralysis
  11. Restenosis following a prior carotid endarterectomy (CEA).

Exclusion Criteria:

  1. Life expectancy of less than one year, cancer with metastatic spread and/or undergoing active chemotherapy treatment, or currently requiring an organ transplantation.
  2. An evolving, acute, or recent disabling stroke in the last 30 days.
  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 fibrillation that requires chronic anticoagulation
  5. History of chronic atrial fibrillation.
  6. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents.
  7. Acute myocardial infarction < 14 days prior to index procedure.
  8. 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.
  9. History of major disabling stroke with substantial residual disability (modified Rankin score ≥ 3)
  10. Known severe carotid stenosis or complete occlusion contralateral to the target lesion requiring treatment within 30 days of the index procedure.
  11. Other neurological deficit not due to stroke that may confound the neurological assessments.
  12. Dementia considered other than mild.
  13. Known hypersensitivity to nitinol or its components (e.g. nickel, titanium).
  14. History of intracranial hemorrhage within 90 days prior to the index procedure.
  15. History of GI bleed within 30 days prior to the index procedure
  16. Chronic renal insufficiency (serum creatinine ≥ 2.5 ml/dL or estimated GFR < 30 cc/min)
  17. History of severe hepatic impairment, malignant hypertension, and/or is morbidly obese.
  18. Known hypersensitivity to contrast media that cannot be adequately premedicated.
  19. Hemoglobin (Hgb) < 8 gm/dL, platelet count < 100,000, INR > 1.5 (irreversible), or heparin-induced thrombocytopenia.
  20. 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
  21. Contraindication to standard of care study medications, including antiplatelet therapy or aspirin.
  22. Currently enrolled in another interventional device or drug study that has not yet reached the primary endpoint.

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, integrated EPD or stent. 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 tiny, long segment of contrast in the true lumen of the artery).
  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. Excessive circumferential calcification of the target lesion is defined as > 3 mm of thickness of calcification seen in orthogonal views on fluoroscopy.
  10. Patient in whom femoral access is not possible. Furthermore, occlusive or critical iliofemoral disease, including severe tortuosity or stenosis that requires additional endovascular procedures to facilitate aortic arch access or that prevents safe and expeditious femoral access to the aortic arch.
  11. Arteriovenous malformations of the territory of the target carotid artery and cerebral vasculature.
  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 safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth K. Saylors, MSc. 919-459-7250 esaylors@contegomedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04201132
Other Study ID Numbers  ICMJE CSP1400
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Contego Medical, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Contego Medical, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William A. Gray, MD Lankenau Heart Institute
Principal Investigator: Ralf Langhoff, MD Sankt Gertrauden Krankenhaus
PRS Account Contego Medical, Inc.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP