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

Carotid Artery Disease Clinical Trial

— ROADSTER  

Official title:

INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685567
• Other study ID #: SRM-2012-02
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2012
• Last updated: December 16, 2016
• Start date: November 2012
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Silk Road Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 stroke with major neurological deficit.

3. Active bleeding diathesis or coagulopathy or will refuse blood transfusion.

4. Had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.

5. Recently (<60 days prior to procedure) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.

6. Recent GI bleed that would interfere with antiplatelet therapy.

7. Life expectance of < 12 months post procedure.

8. History of intolerance or allergic reaction to any of the study medications or stent materials.

9. Myocardial Infarction within 72 hours prior to the intervention.

10. Has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke.

11. 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.

12. Occlusion or (TIMI 0) "string sign" >1cm of the ipsilateral common or internal carotid artery.

13. Has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery.

14. Knowledge of cardiac sources of emboli, Ostium of Common Carotid Artery (CCA) requires revascularization.

15. Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device.

16. Has less than 5cm between the clavicle and bifurcation.

17. Bilateral carotid stenosis if intervention is planned within the 30-day of the index procedure.

18. An intraluminal filling defect that is not associated with an ulcerated target lesion.

19. Abnormal angiographic findings.

20. Previous intervention in the ipsilateral proximal CCA or previous placed intravascular stent in target vessel

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases

Intervention

Device:
• MICHI NPS+f
Cerebral protection with carotid flow reversal

Locations

Country	Name	City	State
Spain	Hospital Virgen de la Salud	Toledo
United States	Albany Medical Center	Albany	New York
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Cardiothoracic & Vascular Surgeons	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University at Buffalo Neurosurgery, Inc	Buffalo	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Case Medical Center and Case Western Reserve University School of Medicine	Cleveland	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Dallas VA Medical Center	Dallas	Texas
United States	Methodist Medical Center	Dallas	Texas
United States	McLaren Regional Medical Center	Flint	Michigan
United States	Greenville Hospital System	Greenville	South Carolina
United States	Peter Morton UCLA Medical Center	Los Angeles	California
United States	Columbia University	New York	New York
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	Oklahoma Heart	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Jobst Vascular Institute	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Silk Road Medical

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke, Myocardial Infarction, and Death	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.	30 days post procedure	Yes
Secondary	Technical Success	The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.	0 to 30 days	No
Secondary	Acute Device Success	The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.	0 to 30 days	No
Secondary	Procedural Success	The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.	0 to 30 days	No
Secondary	Access Site Complications	The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.	0 to 30 days	No
Secondary	Contrast Usage	The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.	0 to 30 days	No
Secondary	Ipsilateral Stroke	Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.	31-365 days	No