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)
1 other identifier
interventional
295
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 18, 2016
CompletedStudy Start
First participant enrolled
April 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedFebruary 28, 2023
February 1, 2023
6 years
January 11, 2016
February 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
All stroke, death, and MI
At 30 days
Ipsilateral stroke
At 12 months
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (1)
Single-arm, open label
EXPERIMENTALTo 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.
Interventions
The Roadsaver™ carotid artery stent system is indicated for use in patients with significant atherosclerotic disease of the carotid arteries.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +17 more criteria
You may not qualify if:
- 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.
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85006, United States
St. Luke's Medical Center
Phoenix, Arizona, 85006, United States
Yavapai Regional Medical Center
Prescott, Arizona, 86301, United States
Kaiser Permanente - Los Angeles
Los Angeles, California, 90027, United States
San Diego VA Medical Center
San Diego, California, 92161, United States
Radiology Imaging Associates
Denver, Colorado, 80112, United States
Swedish Medical Center
Englewood, Colorado, 80112, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Lyerly Baptist Neurosurgery
Jacksonville, Florida, 32207, United States
Kaiser Permanente Moanalua Medical Center - Specialty Clinic
Honolulu, Hawaii, 96816, United States
Prairie Education & Research Cooperative
Springfield, Illinois, 62701, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Albany Medical College
Albany, New York, 12208, United States
University of Buffalo
Buffalo, New York, 14203, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Feinstein Institute for Medical Research
New York, New York, 10075, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
NC Heart and Vascular Research / Rex Hospital
Raleigh, North Carolina, 27607, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
University Hospital
Cleveland, Ohio, 44106, United States
Holy Spirit Cardiology Research
Camp Hill, Pennsylvania, 17011, United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141, United States
Berks Cardiologists
Wyomissing, Pennsylvania, 19610, United States
Black Hills Cardiovascular Research / Regional Health Hospital
Rapid City, South Dakota, 57701, United States
North Central Heart Institute
Sioux Falls, South Dakota, 57108, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Methodist Hospital Memphis-Semmes Murphey
Memphis, Tennessee, 38120, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Baylor Scott White Health
Plano, Texas, 75093, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Multicare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2016
First Posted
January 18, 2016
Study Start
April 21, 2016
Primary Completion
April 8, 2022
Study Completion
May 1, 2024
Last Updated
February 28, 2023
Record last verified: 2023-02