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Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis (PERFORMANCE)

Primary Purpose

Carotid Artery Stenosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)
Sponsored by
Contego Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and non-breastfeeding female subjects whose age is ≥18 years.
  2. Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
  3. Patient is willing to provide written informed consent prior to enrollment in study.
  4. Females of childbearing potential must have documented negative pregnancy test within 7 days of the Index procedure.
  5. Patient is either:

    • Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as transient ischemia attack (TIA) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; or
    • Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology.

7. Patient has a target lesion located at the carotid bifurcation and/or proximal internal carotid artery (ICA).

8. Patient has a single de novo or restenotic (post carotid endarterectomy [CEA]) target lesion or severe tandem lesions close enough that can be covered by a single Neuroguard stent.

9. Target lesion reference vessel diameter between 4.0 and 7.0 mm. 10. Distal vessel diameter at the site of filter deployment between 4.0 mm and 7.0 mm.

11. Sufficient landing zone in the cervical internal carotid artery distal to the lesion to allow for the safe and successful deployment of the primary embolic protection filter (commercially available) and the Neuroguard integrated embolic protection filter.

Exclusion Criteria

  1. Life expectancy of less than one year.
  2. Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke in the last 30 days.
  3. Recently (<30 days) implanted heart valve (either surgically or endovascularly) which is a known source of emboli as confirmed on echocardiogram and anticipated or potential cardiovascular sources of emboli that are not adequately treated with anticoagulants .
  4. History of or current atrial fibrillation or atrial flutter, including paroxysmal atrial fibrillation.
  5. Patient has had an acute myocardial infarction within 72 hours prior to index procedure .
  6. Patient has had or has plans to have any major surgical procedure (i.e. intraabdominal or intrathoracic surgery or any surgery/interventional procedure involving cardiac or vascular system) within 30 days before or after the index procedure.
  7. Patient has known severe carotid stenosis or complete occlusion contralateral to the target lesion requiring treatment within 30 days following the index procedure.
  8. Patient has a modified Rankin Scale (mRS) >2 or has another neurological deficit not due to stroke that may confound the neurological patient assessments (e.g. intracranial tumor).
  9. Patient has chronic renal insufficiency (serum creatinine ≥2.5 ml/dL), end stage renal disease on hemodialysis, a history of severe hepatic impairment or malignant hypertension.
  10. Patient has platelet count < 100,000/uL.
  11. Active bleeding diathesis, hypercoagulable state, or unable to receive blood transfusions.
  12. Patient has a history of intolerance or contraindication to standard of care study medications, including antiplatelet therapy.
  13. Patient has a known hypersensitivity to nickel or titanium.
  14. Sensitivity to heparin or previous incidence of HIT type II.
  15. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or uncorrected bleeding disorders.
  16. Currently enrolled in another interventional device or investigational medication study that has not yet reached the primary endpoint.
  17. Patient has a total occlusion of the target carotid artery.
  18. Patient has a previously placed stent in the ipsilateral carotid artery.
  19. Patient has excessive vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, integrated embolic protection device (EPD) or stent.
  20. Patient has severe calcification of the target lesion that may prevent full expansion of the carotid stent.
  21. Intraluminal mobile filling defect or fresh thrombus in the target lesion.
  22. Occlusion or presence of a string sign in the ipsilateral common or internal carotid artery.
  23. Carotid (intracranial) stenosis located distal to the target lesion that is more severe than the target lesion.
  24. Known mobile plaque or thrombus in the aortic arch.
  25. Patient has a type III aortic arch.
  26. Arteriovenous malformations of the territory of the target carotid artery.

Sites / Locations

  • Sankt Gertrauden-Krankenhaus GmbH
  • Cardiovascular Centre Frankfurt
  • Medizinisches Versorgungszentrum
  • Universitätsklinikum Leipzig
  • Maria Cecelia Hospital
  • Università Frederico II

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carotid artery stenting with Neuroguard IEP System

Arm Description

To evaluate the safety and feasibility of the Neuroguard IEP System when used in patients with clinically significant carotid artery stenosis requiring revascularization.

Outcomes

Primary Outcome Measures

Major Adverse Event (MAE)
Death, stroke, myocardial infarction (MI) within 30 days of the index procedure

Secondary Outcome Measures

Full Information

First Posted
July 26, 2019
Last Updated
November 16, 2022
Sponsor
Contego Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04142541
Brief Title
Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis
Acronym
PERFORMANCE
Official Title
Protection Against Emboli During Carotid Artery Stenting Using a 3-in-1delivery System Comprised of a Post-dilation Balloon, Integrated Embolic Filter, and a Novel Carotid Stent (PERFORMANCE 1 Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
February 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Contego Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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. The PERFORMANCE I study is a multi-center, prospective, single arm open label study to evaluate the safety and feasibility of the Neuroguard IEP System for the treatment of carotid artery stenosis. The primary endpoint will be the proportion of patients with Major Adverse Events (MAE) reported within 30 days from the index procedure. The primary objective of the PERFORMANCE I study is to evaluate the safety and feasibility of the Neuroguard IEP Carotid Stent System when used in patients with clinically significant carotid artery stenosis requiring revascularization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Carotid artery stenting with Neuroguard IEP System
Arm Type
Experimental
Arm Description
To evaluate the safety and feasibility of the Neuroguard IEP System when used in patients with clinically significant carotid artery stenosis requiring revascularization.
Intervention Type
Device
Intervention Name(s)
Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)
Intervention Description
The Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection is indicated for improving the carotid luminal diameter in patients with clinically significant carotid artery stenosis and for the simultaneous capture and removal of embolic material during angioplasty and stenting.
Primary Outcome Measure Information:
Title
Major Adverse Event (MAE)
Description
Death, stroke, myocardial infarction (MI) within 30 days of the index procedure
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and non-breastfeeding female subjects whose age is ≥18 years. Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone. Patient is willing to provide written informed consent prior to enrollment in study. Females of childbearing potential must have documented negative pregnancy test within 7 days of the Index procedure. Patient is either: Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as transient ischemia attack (TIA) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; or Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology. 7. Patient has a target lesion located at the carotid bifurcation and/or proximal internal carotid artery (ICA). 8. Patient has a single de novo or restenotic (post carotid endarterectomy [CEA]) target lesion or severe tandem lesions close enough that can be covered by a single Neuroguard stent. 9. Target lesion reference vessel diameter between 4.0 and 7.0 mm. 10. Distal vessel diameter at the site of filter deployment between 4.0 mm and 7.0 mm. 11. Sufficient landing zone in the cervical internal carotid artery distal to the lesion to allow for the safe and successful deployment of the primary embolic protection filter (commercially available) and the Neuroguard integrated embolic protection filter. Exclusion Criteria Life expectancy of less than one year. Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke in the last 30 days. Recently (<30 days) implanted heart valve (either surgically or endovascularly) which is a known source of emboli as confirmed on echocardiogram and anticipated or potential cardiovascular sources of emboli that are not adequately treated with anticoagulants . History of or current atrial fibrillation or atrial flutter, including paroxysmal atrial fibrillation. Patient has had an acute myocardial infarction within 72 hours prior to index procedure . Patient has had or has plans to have any major surgical procedure (i.e. intraabdominal or intrathoracic surgery or any surgery/interventional procedure involving cardiac or vascular system) within 30 days before or after the index procedure. Patient has known severe carotid stenosis or complete occlusion contralateral to the target lesion requiring treatment within 30 days following the index procedure. Patient has a modified Rankin Scale (mRS) >2 or has another neurological deficit not due to stroke that may confound the neurological patient assessments (e.g. intracranial tumor). Patient has chronic renal insufficiency (serum creatinine ≥2.5 ml/dL), end stage renal disease on hemodialysis, a history of severe hepatic impairment or malignant hypertension. Patient has platelet count < 100,000/uL. Active bleeding diathesis, hypercoagulable state, or unable to receive blood transfusions. Patient has a history of intolerance or contraindication to standard of care study medications, including antiplatelet therapy. Patient has a known hypersensitivity to nickel or titanium. Sensitivity to heparin or previous incidence of HIT type II. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or uncorrected bleeding disorders. Currently enrolled in another interventional device or investigational medication study that has not yet reached the primary endpoint. Patient has a total occlusion of the target carotid artery. Patient has a previously placed stent in the ipsilateral carotid artery. Patient has excessive vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, integrated embolic protection device (EPD) or stent. Patient has severe calcification of the target lesion that may prevent full expansion of the carotid stent. Intraluminal mobile filling defect or fresh thrombus in the target lesion. Occlusion or presence of a string sign in the ipsilateral common or internal carotid artery. Carotid (intracranial) stenosis located distal to the target lesion that is more severe than the target lesion. Known mobile plaque or thrombus in the aortic arch. Patient has a type III aortic arch. Arteriovenous malformations of the territory of the target carotid artery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Cremonesi, MD
Organizational Affiliation
Maria Cecelia Hospital Cotignola
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sankt Gertrauden-Krankenhaus GmbH
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Cardiovascular Centre Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Medizinisches Versorgungszentrum
City
Hamburg
ZIP/Postal Code
22527
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Maria Cecelia Hospital
City
Cotignola
ZIP/Postal Code
48033
Country
Italy
Facility Name
Università Frederico II
City
Naples
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36229946
Citation
Langhoff R, Petrov I, Kedev S, Milosevic Z, Schmidt A, Scheinert D, Schofer J, Sievert H, Sedgewick G, Saylors E, Sachar R, Cremonesi A, Micari A. PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device. Catheter Cardiovasc Interv. 2022 Nov;100(6):1090-1099. doi: 10.1002/ccd.30410. Epub 2022 Oct 13.
Results Reference
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Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis

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