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

Sponsor

Microvention-Terumo, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02657707

Collaborator

(none)

295

Enrollment

Locations

Arm

96.3

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 events following carotid endarterectomy.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenosis	Device: Roadsaver™ Carotid Artery Stent Device Device: Nanoparasol® Embolic Protection System	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

295 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Apr 21, 2016

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

All stroke, death, and MI [At 30 days]
Ipsilateral stroke [At 12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
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.

Exclusion Criteria:

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.
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

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