Clinical trial NCT02657707: Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Artery Stenosis
Keywords: stent
stenosis
artery
carotid
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-18
Enrollment: 295
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All stroke, death, and MI
timeFrame: At 30 days
measure: Ipsilateral stroke
timeFrame: At 12 months
Secondary outcomes:
measure: Successful deployment of stent
timeFrame: Procedure day
measure: Successful completion of procedure
timeFrame: Procedure day
measure: Successful deployment and retrieval of embolic protection device
timeFrame: Procedure day
measure: Target lesion revascularization (TLR)
timeFrame: At 6 and 12 months
measure: In-stent restenosis
timeFrame: At 6 and 12 months
measure: Major stroke
timeFrame: At 30 days
measure: Minor stroke
timeFrame: At 30 days
measure: Transient ischemic attack (TIA)
timeFrame: Within 30 days
measure: Neurologic death
timeFrame: At 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Hospital
state: Arizona
city: Phoenix
country: United States
facility: St. Luke's Medical Center
state: Arizona
city: Prescott
country: United States
facility: Yavapai Regional Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Kaiser Permanente - Los Angeles
state: California
city: San Diego
country: United States
facility: San Diego VA Medical Center
state: California
city: Denver
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Lyerly Baptist Neurosurgery
state: Florida
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center - Specialty Clinic
state: Hawaii
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Lebanon
country: United States
facility: Darthmouth-Hitchcock Medical Center
state: New Hampshire
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Raleigh
country: United States
facility: NC Heart and Vascular Research / Rex Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospital
state: Ohio
city: Camp Hill
country: United States
facility: Holy Spirit Cardiology Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Cardiovascular Research / Regional Health Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Knoxville
country: United States
facility: Tennova Healthcare - Turkey Creek Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Methodist Hospital Memphis-Semmes Murphey
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Plano
country: United States
facility: Baylor Scott White Health
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Tacoma
country: United States
facility: Multicare Institute for Research and Innovation
state: Washington
Study officials:
affiliation: University of Buffalo - Neurosurgery
name: Adnan Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wellmont CVA Heart Institute
name: Chris Metzger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente Moanalua Medical Center
name: Peter Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References: