Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis

Pivotal Study of the MicroVention, Inc. Carotid Artery Stent System Used in Conjunction With the Nanoparasol® Embolic Protection System for the Treatment of Carotid Artery Stenosis in Patients at Elevated Risk for Adverse Events From Carotid Endarterectomy.(CONFIDENCE Trial)

A prospective, multicenter, single-arm, open label clinical study to evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy.

Study Overview

• Status: Active, not recruiting
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: Roadsaver™ Carotid Artery Stent Device; Device: Nanoparasol® Embolic Protection System

Detailed Description

Up to 295 patients will be enrolled for this study. All potential patients being considered for the study should have been diagnosed with significant carotid artery stenosis and be considered a high perioperative risk for carotid endarterectomy.

Patients will be evaluated through screening, pre-procedure, index procedure, post-procedure. Follow-up visits will be completed at 30 days, 6 months, and 12, 24, and 36 months post-procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 295
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • St. Luke's Medical Center
    • Phoenix, Arizona, United States, 85006
      • Abrazo Arizona Heart Hospital
    • Prescott, Arizona, United States, 86301
      • Yavapai Regional Medical Center
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente - Los Angeles
    • San Diego, California, United States, 92161
      • San Diego VA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80112
      • Radiology Imaging Associates
    • Englewood, Colorado, United States, 80112
      • Swedish Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Lyerly Baptist Neurosurgery
  • Hawaii
    • Honolulu, Hawaii, United States, 96816
      • Kaiser Permanente Moanalua Medical Center - Specialty Clinic
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Prairie Education & Research Cooperative
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Darthmouth-Hitchcock Medical Center
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Overlook Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Buffalo, New York, United States, 14203
      • University of Buffalo
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10075
      • Feinstein Institute for Medical Research
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research / Rex Hospital
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospital
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Holy Spirit Cardiology Research
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Healthcare Network
    • Wyomissing, Pennsylvania, United States, 19610
      • Berks Cardiologists
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Cardiovascular Research / Regional Health Hospital
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart Institute
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute
    • Knoxville, Tennessee, United States, 37934
      • Tennova Healthcare - Turkey Creek Medical Center
    • Memphis, Tennessee, United States, 38120
      • Methodist Hospital Memphis-Semmes Murphey
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Plano, Texas, United States, 75093
      • Baylor Scott White Health
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is between >21 and ≤80 years of age.
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 or authorized legal representative is willing to provide written informed consent prior to enrollment in study.
4. Patient should have been diagnosed with carotid artery stenosis and be considered a high operative risk for carotid endarterectomy.

5. Patient is either:

   • Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; 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.
6. Patient has a target lesion located at the carotid bifurcation and/or proximal ICA.
7. Patient has a single de novo or restenotic (post CEA) target lesion or severe tandem lesions close enough that can be covered by a single Roadsaver™ stent.
8. Patients having a vessel with reference diameters between 3.0 mm and 9.0 mm at the target lesion.

High Risk Inclusion Criteria

For inclusion in the study, a patient must qualify in at least one anatomic or co-morbid high-risk condition, as shown below:

Anatomic High Risk Conditions:

1. Patient has a target lesion at or above the second vertebral body (level of jaw) or below the clavicle.
2. Patient has an inability to extend the head due to cervical arthritis or other cervical disorders.
3. Patient is status/post radiation therapy to the neck.
4. Patient has a prior head and neck surgery in the region of the carotid artery.
5. Patient has spinal immobility of the neck.
6. Patient has the presence of tracheostomy stoma.
7. Patient has laryngeal palsy or laryngectomy.
8. Patient has a hostile neck or surgically inaccessible lesion.
9. Patient has severe tandem lesions.

Co-morbid High Risk Conditions:

1. Patient is ≥70 years of age (maximum 80 years) at the time of enrollment.
2. Patient has NYHA Class III or IV congestive heart failure (CHF) with LVEF <35%.
3. Patient has chronic obstructive pulmonary disease (COPD) with FEV <30%.
4. Patient has unstable angina.
5. Patient has had a recent myocardial infarction (≥30 days prior to stenting procedure).
6. Patient has coronary artery disease with two or more vessels with ≥ 70% stenosis.
7. Patient has planned CABG or valve replacement surgery between 31-60 days after the CAS procedure.
8. Patient requires peripheral vascular surgery or abdominal aortic aneurysm repair between 31-60 days following the CAS procedure.
9. Patient has contralateral laryngeal nerve paralysis
10. Patient has restenosis after a previous CEA.
11. Patient has contralateral occlusion in the ICA as the only comorbid high risk condition.

Exclusion Criteria:

1. Patient has 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. Patient has anticipated or potential sources of emboli (e.g. known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or deep vein thrombosis (DVT) treated within 6 months) that are not adequately treated with antithrombotics for at least two weeks with documented coagulation parameters in the target therapeutic range.
4. Patient has atrial fibrillation.
5. Patient has had an acute myocardial infarction within 60 days prior to index procedure.
6. Patient has had or 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 of the index procedure.
7. Patient has a history of major ipsilateral stroke.
8. Patient has >60% carotid stenosis contralateral to the target lesion requiring treatment prior to completion of thes study-required 12 month follow-up.
9. Patient has a modified Rankin Scale of >2 or has another neurological deficit not due to stroke that may confound the neurological patient assessments.
10. Patient has chronic renal insufficiency (serum creatinine ≥2.5 mg/dL) or has a history of severe hepatic impairment, malignant hypertension, and/or is morbidly obese.
11. Patient has platelet count <100,000/μL.
12. Patient has known sensitivity to heparin or previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II.
13. Patient has contraindication to standard of care study medications, including antiplatelet therapy.
14. Patient has known sensitivity to contrast media that cannot be adequately controlled with premedication.
15. Patient has known bleeding diathesis or hypercoagulable state or refuses blood transfusions.
16. Patient has intracranial pathology that, in the opinion of the investigator, makes the patient inappropriate for study participation (e.g. brain tumor, AVM, cerebral aneurysm, cerebral vascular disease [microangiopathy or large vessel], etc.) or would confound neurological evaluation.
17. Patient had intracranial hemorrhage within the last 90 days.
18. Patient is currently enrolled in another investigational study protocol and has not completed its primary endpoint or that will confound the current study endpoints. Patients who are involved in the long-term surveillance of a clinical study are eligible.
19. Patient suffers from confusion or dementia or is unable or unwilling to cooperate with the study requirements and/or follow-up procedures.
20. Patient has a known, unresolved history of drug use or alcohol dependency.
21. Patient has an active infection.
22. Patient has renal failure and/or is on dialysis.
23. Patient has documented uncontrolled diabetes.
24. Patient is pregnant.

Angiographic Exclusion Criteria

A patient is not eligible for enrollment in the study if he/she meets any of the following angiographic exclusion criteria:

1. Patient has a total occlusion of the target carotid arteries (i.e., CCA or ICA).
2. Patient has a previously placed stent in the ipsilateral carotid artery.
3. Patient has severe lesion calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, embolic protection system, or stent.
4. Patient has the presence of mobile filling defect or thrombus in target vessel.
5. Patient has occlusion or presence of "string sign" of the target vessel.
6. Patient has carotid (intracranial) stenosis located distal to target stenosis that is more severe than target stenosis.
7. Patient has known mobile plaque or thrombus in the aortic arch.
8. Patient has a type III aortic arch.
9. Patient in whom femoral access is not possible.
10. Patient has intracranial arteriovenous malformations of the territory of the target carotid artery.
11. Patient has an aneurysm in the territory of the target carotid artery that requires treatment within 12 months.
12. Patient's ipsilateral carotid artery has 2 or more 90 degree bends in the target landing zone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single-arm, open label; To evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy.

Device: Roadsaver™ Carotid Artery Stent Device; The Roadsaver™ carotid artery stent system is indicated for use in patients with significant atherosclerotic disease of the carotid arteries.; Device: Nanoparasol® Embolic Protection System; The Nanoparasol® embolic protection system is indicated for use with a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All stroke, death, and MI	At 30 days
Ipsilateral stroke	At 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Successful deployment of stent	Procedure day
Successful completion of procedure	Procedure day
Successful deployment and retrieval of embolic protection device	Procedure day
Target lesion revascularization (TLR)	At 6 and 12 months
In-stent restenosis	At 6 and 12 months
Major stroke	At 30 days
Minor stroke	At 30 days
Transient ischemic attack (TIA)	Within 30 days
Neurologic death	At 12 months

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Investigators: Principal Investigator: Adnan Siddiqui, MD, University of Buffalo - Neurosurgery; Principal Investigator: Chris Metzger, MD, Wellmont CVA Heart Institute; Principal Investigator: Peter Schneider, MD, Kaiser Permanente Moanalua Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2016
• Primary Completion (Actual): April 8, 2022
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: stent; stenosis; carotid; artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: CL11003