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Carotid Artery StenosisNCT02657707

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

A study testing Roadsaver™ Carotid Artery Stent Device and Nanoparasol® Embolic Protection System in people with Carotid Artery Stenosis, run by Microvention-Terumo, Inc. at 37 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Carotid Artery Stenosis
What is being tested?
Roadsaver™ Carotid Artery Stent Device and Nanoparasol® Embolic Protection System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
295 participants
Where
37 sitesUnited States
Study dates
21 Apr 2016to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is between >21 and ≤80 years of age.
  • Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
  • Patient or authorized legal representative is willing to provide written informed consent prior to enrollment in study.
  • Patient should have been diagnosed with carotid artery stenosis and be considered a high operative risk for carotid endarterectomy.
  • 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
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  • Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology.
  • Patient has a target lesion located at the carotid bifurcation and/or proximal ICA.
  • 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.
  • 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:
  • Patient has a target lesion at or above the second vertebral body (level of jaw) or below the clavicle.
  • Patient has an inability to extend the head due to cervical arthritis or other cervical disorders.
  • Patient is status/post radiation therapy to the neck.
  • Patient has a prior head and neck surgery in the region of the carotid artery.
  • Patient has spinal immobility of the neck.
  • Patient has the presence of tracheostomy stoma.
  • Patient has laryngeal palsy or laryngectomy.
  • Patient has a hostile neck or surgically inaccessible lesion.
  • Patient has severe tandem lesions.
  • Co-morbid High Risk Conditions:
  • Patient is ≥70 years of age (maximum 80 years) at the time of enrollment.
  • Patient has NYHA Class III or IV congestive heart failure (CHF) with LVEF <35%.
  • Patient has chronic obstructive pulmonary disease (COPD) with FEV <30%.
  • Patient has unstable angina.
  • Patient has had a recent myocardial infarction (≥30 days prior to stenting procedure).
  • Patient has coronary artery disease with two or more vessels with ≥ 70% stenosis.
  • Patient has planned CABG or valve replacement surgery between 31-60 days after the CAS procedure.
  • Patient requires peripheral vascular surgery or abdominal aortic aneurysm repair between 31-60 days following the CAS procedure.
  • Patient has contralateral laryngeal nerve paralysis
  • Patient has restenosis after a previous CEA.
  • Patient has contralateral occlusion in the ICA as the only comorbid high risk condition.

Who cannot join

  • Patient has 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.
  • 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.
  • Patient has atrial fibrillation.
  • Patient has had an acute myocardial infarction within 60 days prior to index procedure.
  • 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.
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  • Patient has a history of major ipsilateral stroke.
  • Patient has >60% carotid stenosis contralateral to the target lesion requiring treatment prior to completion of thes study-required 12 month follow-up.
  • Patient has a modified Rankin Scale of >2 or has another neurological deficit not due to stroke that may confound the neurological patient assessments.
  • 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.
  • Patient has platelet count <100,000/μL.
  • Patient has known sensitivity to heparin or previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II.
  • Patient has contraindication to standard of care study medications, including antiplatelet therapy.
  • Patient has known sensitivity to contrast media that cannot be adequately controlled with premedication.
  • Patient has known bleeding diathesis or hypercoagulable state or refuses blood transfusions.
  • 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.
  • Patient had intracranial hemorrhage within the last 90 days.
  • 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.
  • Patient suffers from confusion or dementia or is unable or unwilling to cooperate with the study requirements and/or follow-up procedures.
  • Patient has a known, unresolved history of drug use or alcohol dependency.
  • Patient has an active infection.
  • Patient has renal failure and/or is on dialysis.
  • Patient has documented uncontrolled diabetes.
  • 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:
  • Patient has a total occlusion of the target carotid arteries (i.e., CCA or ICA).
  • Patient has a previously placed stent in the ipsilateral carotid artery.
  • Patient has severe lesion calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, embolic protection system, or stent.
  • Patient has the presence of mobile filling defect or thrombus in target vessel.
  • Patient has occlusion or presence of "string sign" of the target vessel.
  • Patient has carotid (intracranial) stenosis located distal to target stenosis that is more severe than target stenosis.
  • Patient has known mobile plaque or thrombus in the aortic arch.
  • Patient has a type III aortic arch.
  • Patient in whom femoral access is not possible.
  • Patient has intracranial arteriovenous malformations of the territory of the target carotid artery.
  • Patient has an aneurysm in the territory of the target carotid artery that requires treatment within 12 months.
  • Patient's ipsilateral carotid artery has 2 or more 90 degree bends in the target landing zone.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • Albany Medical College

    Albany, New York, 12208

  • University of Buffalo

    Buffalo, New York, 14203

  • Holy Spirit Cardiology Research

    Camp Hill, Pennsylvania, 17011

  • University Hospital

    Cleveland, Ohio, 44106

  • Radiology Imaging Associates

    Denver, Colorado, 80112

  • Swedish Medical Center

    Englewood, Colorado, 80112

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Kaiser Permanente Moanalua Medical Center - Specialty Clinic

    Honolulu, Hawaii, 96816

  • Lyerly Baptist Neurosurgery

    Jacksonville, Florida, 32207

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • Darthmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Bryan Heart

    Lincoln, Nebraska, 68506

  • Kaiser Permanente - Los Angeles

    Los Angeles, California, 90027

  • Methodist Hospital Memphis-Semmes Murphey

    Memphis, Tennessee, 38120

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Feinstein Institute for Medical Research

    New York, New York, 10075

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Albert Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141

  • Abrazo Arizona Heart Hospital

    Phoenix, Arizona, 85006

  • St. Luke's Medical Center

    Phoenix, Arizona, 85006

  • Baylor Scott White Health

    Plano, Texas, 75093

  • Yavapai Regional Medical Center

    Prescott, Arizona, 86301

  • NC Heart and Vascular Research / Rex Hospital

    Raleigh, North Carolina, 27607

  • Black Hills Cardiovascular Research / Regional Health Hospital

    Rapid City, South Dakota, 57701

  • San Diego VA Medical Center

    San Diego, California, 92161

  • North Central Heart Institute

    Sioux Falls, South Dakota, 57108

  • Prairie Education & Research Cooperative

    Springfield, Illinois, 62701

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Overlook Medical Center

    Summit, New Jersey, 07901

  • Multicare Institute for Research and Innovation

    Tacoma, Washington, 98405

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Berks Cardiologists

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Roadsaver™ Carotid Artery Stent Device, Nanoparasol® Embolic Protection System
Keywords
stent, stenosis, artery, carotid
Medical subject headings
Carotid Stenosis, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roadsaver™ Carotid Artery Stent DeviceDevice

    The Roadsaver™ carotid artery stent system is indicated for use in patients with significant atherosclerotic disease of the carotid arteries.

  • Nanoparasol® Embolic Protection SystemDevice

    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.

Study groups in NCT02657707
Study groupRoleWhat they receive
Single-arm, open labelExperimentalTo 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.
Receives: Device: Roadsaver™ Carotid Artery Stent Device; Device: Nanoparasol® Embolic Protection System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All stroke, death, and MI

    Measured: At 30 days

  2. Ipsilateral stroke

    Measured: At 12 months

Secondary outcomes (9)

  1. Successful deployment of stent

    Measured: Procedure day

  2. Successful completion of procedure

    Measured: Procedure day

  3. Successful deployment and retrieval of embolic protection device

    Measured: Procedure day

  4. Target lesion revascularization (TLR)

    Measured: At 6 and 12 months

  5. In-stent restenosis

    Measured: At 6 and 12 months

  6. Major stroke

    Measured: At 30 days

  7. Minor stroke

    Measured: At 30 days

  8. Transient ischemic attack (TIA)

    Measured: Within 30 days

  9. Neurologic death

    Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2016 (estimated)
  2. Study start21 Apr 2016
  3. Primary completion8 Apr 2022
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
295 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02657707
Sponsor's protocol ID
CL11003
Status last verified
Feb 2023
First submitted
11 Jan 2016
Last updated
28 Feb 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Roadsaver™ Carotid Artery Stent Device and Nanoparasol® Embolic Protection System in people with Carotid Artery Stenosis, run by Microvention-Terumo, Inc. at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All stroke, death, and MI (time frame: At 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02657707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.

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