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

September 10, 2012
August 12, 2013
November 2012
December 2014   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01685567 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure
INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Carotid Artery Disease
Device: MICHI NPS+f
Cerebral protection with carotid flow reversal
Other Name: MICHI NPS+f
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.
Intervention: Device: MICHI NPS+f
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States,   Spain
 
NCT01685567
SRM-2012-02
Yes
Silk Road Medical
Silk Road Medical
Not Provided
Principal Investigator: Christopher Kwolek, MD Massachusetts General Hospital
Principal Investigator: Richard Cambria, MD Massachusetts General Hospital
Silk Road Medical
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP