Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)

This study is currently recruiting participants.
Verified August 2013 by Silk Road Medical
Sponsor:
Information provided by (Responsible Party):
Silk Road Medical
ClinicalTrials.gov Identifier:
NCT01685567
First received: September 10, 2012
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of the MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) in providing cerebral embolic protection during carotid artery stenting. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.


Condition Intervention Phase
Carotid Artery Disease
Device: MICHI NPS+f
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.

Resource links provided by NLM:


Further study details as provided by Silk Road Medical:

Primary Outcome Measures:
  • Stroke, Myocardial Infarction, and Death [ Time Frame: 30 days post procedure ] [ Designated as safety issue: Yes ]
    The primary endpoint for overall evaluation of the study is a composite endpoint consisting of the first occurrence of any of the following major adverse events within 30 days.


Secondary Outcome Measures:
  • Technical Success [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]
    The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.

  • Acute Device Success [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]
    The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.

  • Procedural Success [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]
    The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.

  • Access Site Complications [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]
    The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.

  • Contrast Usage [ Time Frame: 0 to 30 days ] [ Designated as safety issue: No ]
    The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.


Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MICHI NPS+f
The MICHI™ NPS+f is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify to the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.
Device: MICHI NPS+f
Cerebral protection with carotid flow reversal
Other Name: MICHI NPS+f

Detailed Description:

Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy (CEA). Many currently available embolic protection devices, however, have limited efficacy in capturing microembolic debris that is liberated during stenting, pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the need to cross the lesion prior to deployment. Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed.

Cerebral protection with carotid flow reversal is a method that was developed as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Another technique developed employs carotid flow reversal prior to traversing the stenosis and can be accomplished by directly accessing the carotid anatomy without the use of the transfemoral approach. Major benefits to this method include a simpler route to the target lesion and the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:

    • Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure.
    • Asymptomatic: Stenosis must be greater than or equal to 70% as determined by angiogram without any neurological symptoms within the prior 180 days.
  2. Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
  3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
  4. Patient is >18 years of age.
  5. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
  6. Patient (or their legal guardian) understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
  7. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
  8. Patient meets at least one surgical high-risk criteria.

Exclusion Criteria:

  1. Chronic atrial fibrillation, any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
  2. Evolving stroke, severe dementia, intracranial tumor, history of spontaneous intracranial hemorrhage within the past 12 months, recent stroke of sufficient size, hemorrhagic transformation of an ischemic stroke within the past 60 days, history of major ipsilateral stroke with major neurological deficit.
  3. Active bleeding diathesis or coagulopathy or will refuse blood transfusion.
  4. Had or will have CABG or vascular surgery within 30 days before or after the intervention.
  5. Recent GI bleed that would interfere with antiplatelet therapy.
  6. Life expectance of < 12 months post procedure.
  7. History of intolerance or allergic reaction to any of the study medications or stent materials.
  8. Myocardial Infarction within 72 hours prior to the intervention.
  9. Has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke.
  10. Has Hgb <10 g/dl, platelet count <125,000/μl, uncorrected INR >1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia.
  11. Occlusion or (TIMI 0) "string sign" >1cm of the ipsilateral common or internal carotid artery.
  12. Has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery.
  13. Knowledge of cardiac sources of emboli, Ostium of Common Carotid Artery (CCA) requires revascularization.
  14. Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device.
  15. Has less than 5cm between the clavicle and bifurcation.
  16. Bilateral carotid stenosis if intervention is planned within the 30-day of the index procedure.
  17. An intraluminal filling defect that is not associated with an ulcerated target lesion.
  18. Abnormal angiographic findings.
  19. Previous intervention in the ipsilateral proximal CCA or previous placed intravascular stent in target vessel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685567

Locations
United States, California
Peter Morton UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Kathy Walden    310-206-1115    kgwalden@mednet.ucla.edu   
Principal Investigator: Wes Moore, MD         
United States, Florida
Florida Hospital Active, not recruiting
Orlando, Florida, United States, 32804
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jennifer Finn, RN    617-726-4957    jfinn1@partners.org   
Principal Investigator: Christopher Kwolek, MD         
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109-5967
Contact: Sue Blackburn    734-936-8556    susablac@med.umich.edu   
Principal Investigator: Enrique Criado-Pallares, MD         
McLaren Regional Medical Center Recruiting
Flint, Michigan, United States, 48507
Contact: Maureen Angles    810-600-2009    maureena@michiganvascular.com   
Principal Investigator: Robert Molnar, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Theresa LaRose, RN, BSN    314-362-6257    laroset@wudosis.wustl.edu   
Principal Investigator: Jeffery Jim, MD         
United States, New York
University at Buffalo Neurosurgery, Inc Recruiting
Buffalo, New York, United States, 14203
Contact: Jennifer Gay    716-218-1000 ext 5111    Jgay@UBNS.com   
Principal Investigator: L. Nick Hopkins, MD, FACS         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Kate Dalton, MS, RD    212-342-1820    keb2114@columbia.edu   
Principal Investigator: Philip Meyers, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44106
Contact: Erica Seymour    216-444-0922    seymoue@ccf.org   
Principal Investigator: Daniel Clair, MD         
University Hospitals Case Medical Center and Case Western Reserve University School of Medicine Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lori Hammer, RN, BSN    216-983-4719    Lori.Hammer@UHhospitals.org   
Principal Investigator: Vikram Kashyap, MD         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Nancy Sample       NSAMPLE@OhioHealth.com   
Contact: Brittany Latoche, RN, BSN    614-566-1257    blatoch2@ohiohealth.com   
Principal Investigator: Gary Ansel, MD         
Jobst Vascular Institute Recruiting
Toledo, Ohio, United States, 43606
Contact: Regina Zoller, BSN, RN    419-291-2087    regina.zoller@promedica.org   
Principal Investigator: John Piggott, MD         
United States, Oklahoma
Oklahoma Heart Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Tammy Ramsey    405-608-1287    tramsey@okheart.com   
Principal Investigator: Jim Melton, MD         
United States, South Carolina
Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29615
Contact: Elizabeth Steele    864-454-8294    esteele@ghs.org   
Principal Investigator: Tod Hanover, MD         
United States, Texas
Cardiothoracic & Vascular Surgeons Recruiting
Austin, Texas, United States, 78756
Contact: Donna Johnson, RN       DONNA@ctvstexas.com   
Principal Investigator: Mazin Foteh, MD         
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Luis F. Gomez, MD    214-857-0336    luis.gomez@va.gov   
Principal Investigator: Carlos H. Timaran, MD         
Methodist Medical Center Recruiting
Dallas, Texas, United States, 75208
Contact: Kaitlyn Egan    214-946-5165    kegan@dfwvascular.com   
Principal Investigator: Sam Ahn, MD         
United States, Virginia
Sentara Vascular Specialists Recruiting
Norfolk, Virginia, United States, 23507
Contact: Ellesia Wright, LPN, CRC    757-622-2649    ELWRIGH2@sentara.com   
Principal Investigator: Rasesh M Shah, MD         
Spain
Hospital Virgen de la Salud Recruiting
Toledo, Spain, 45004
Contact: Gino Mariën       GMarien@SILKROADMED.COM   
Principal Investigator: Ignacio Leal, MD         
Sponsors and Collaborators
Silk Road Medical
Investigators
Principal Investigator: Christopher Kwolek, MD Massachusetts General Hospital
Principal Investigator: Richard Cambria, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Silk Road Medical
ClinicalTrials.gov Identifier: NCT01685567     History of Changes
Other Study ID Numbers: SRM-2012-02
Study First Received: September 10, 2012
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Silk Road Medical:
carotid artery disease
reverse flow

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014