Carotid Artery DiseasePhase 3ROADSTERNCT01685567
Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure
A Phase 3 study testing MICHI NPS+f in people with Carotid Artery Disease, run by Silk Road Medical at 21 sites in 2 countries.
Trial summary
The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease
- What is being tested?
- MICHI NPS+f
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Nov 2012to Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
- Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- Patient is greater or equal to 18 years of age.
Show all 10Show fewer
- Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
- Patient 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.
- Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
- Patient meets at least one of the anatomic or clinical high-risk criteria.
Who cannot join
- Patient has chronic atrial fibrillation.
- Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
- Patient has an evolving stroke.
- Patient has severe dementia.
- Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
- Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.
Show all 34Show fewer
- Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
- Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusion.
- Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.
- Patient has had a recent GI bleed that would interfere with antiplatelet therapy.
- Life expectancy of < 12 months post procedure.
- Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, prasugrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine, ASA and clopidogrel or ASA and prasugrel.
- Myocardial Infarction within 72 hours prior to the intervention.
- Presence of a previous placed intravascular stent in target vessel or the planned arteriotomy site.
- Patient has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke (e.g. partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, moderate to severe dementia, or intracranial hemorrhage).
- Patient with a history of major stroke (CVA or retinal embolus) with major neurological deficit likely to confound study endpoints within 1 month of index procedure.
- Patient 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.
- Patient has an intracranial tumor.
- Patient is actively participating in another drug or device trial (IND or IDE) that has not completed the required protocol follow-up period.
- Patient has inability to understand and cooperate with study procedures or provide informed consent.
- Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
- Patient has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery.
- Knowledge of cardiac sources of emboli.e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).
- Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.
- Ostium of Common Carotid Artery (CCA) requires revascularization.
- Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device.
- The patient has less than 5cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound.
- Bilateral carotid stenosis if intervention is planned within 37 days of the index procedure.
- An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) that is not associated with an ulcerated target lesion.
- Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
- Patient has had a previous intervention in the ipsilateral proximal CCA.
- Patient has had a TIA or amaurosis fugax within 48 hours prior to the procedure.
- Patient has contralateral lateral recurrent, laryngeal or vagus nerve injury.
- Patient is otherwise unsuitable for intervention in the opinion of the investigator.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Albany Medical Center
Albany, New York, 12208
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-5967
Cardiothoracic & Vascular Surgeons
Austin, Texas, 78756
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Massachusetts General Hospital
Boston, Massachusetts, 02114
University at Buffalo Neurosurgery, Inc
Buffalo, New York, 14203
Cleveland Clinic Foundation
Cleveland, Ohio, 44106
University Hospitals Case Medical Center and Case Western Reserve University School of Medicine
Cleveland, Ohio, 44106
Riverside Methodist Hospital
Columbus, Ohio, 43214
Methodist Medical Center
Dallas, Texas, 75208
Dallas VA Medical Center
Dallas, Texas, 75216
McLaren Regional Medical Center
Flint, Michigan, 48507
Greenville Hospital System
Greenville, South Carolina, 29615
Peter Morton UCLA Medical Center
Los Angeles, California, 90095
Columbia University
New York, New York, 10032
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Oklahoma Heart
Oklahoma City, Oklahoma, 73120
Florida Hospital
Orlando, Florida, 32804
Washington University School of Medicine
St Louis, Missouri, 63110
Jobst Vascular Institute
Toledo, Ohio, 43606
About this study
Official title: 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 obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.
Read the 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.
- Conditions
- Carotid Artery Disease
- Being tested
- MICHI NPS+f
- Keywords
- carotid artery disease, reverse flow
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICHI NPS+fDevice
Also called ENROUTE Transcarotid Neuroprotection System
Cerebral protection with carotid flow reversal
| Study group | Role | What they receive |
|---|---|---|
| MICHI NPS+f | Experimental | 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. Receives: Device: MICHI NPS+f |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical Composite of Stroke, Myocardial Infarction, and Death
The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.
Measured: 30-day post-procedure
Secondary outcomes (4)
All Death (Non-hierarchical)
The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
Measured: 0 to 30 days
All Myocardial Infarctions (Non-hierarchical)
The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
Measured: 0 to 30 days
All Stroke (Non-hierarchical)
The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
Measured: 0 to 30 days
Ipsilateral Stroke (Non-hierarchical)
Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.
Measured: 31-365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Road Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Kwolek, MD, Principal investigator, Massachusetts General HospitalRichard Cambria, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685567
- Sponsor's protocol ID
- SRM-2012-02
- Acronym
- ROADSTER
- Status last verified
- Jun 2017
- First submitted
- 10 Sep 2012
- Last updated
- 7 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kwolek CJ, Jaff MR, Leal JI, Hopkins LN, Shah RM, Hanover TM, Macdonald S, Cambria RP. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015 Nov;62(5):1227-34. doi: 10.1016/j.jvs.2015.04.460.
PubMed 26506270Alpaslan A, Wintermark M, Pinter L, Macdonald S, Ruedy R, Kolvenbach R. Transcarotid Artery Revascularization With Flow Reversal. J Endovasc Ther. 2017 Apr;24(2):265-270. doi: 10.1177/1526602817693607. Epub 2017 Feb 17.
PubMed 28335706Chung J, Kumins NH, Smith J, Motaganahalli RL, Schneider PA, Kwolek CJ, Kashyap VS; ROADSTER Investigators. Physiologic risk factors increase risk of myocardial infarction with transcarotid artery revascularization in prospective trials. J Vasc Surg. 2023 Apr;77(4):1192-1198. doi: 10.1016/j.jvs.2022.12.013. Epub 2022 Dec 20.
PubMed 36563712Malas MB, Leal Lorenzo JI, Nejim B, Hanover TM, Mehta M, Kashyap V, Kwolek CJ, Cambria R. Analysis of the ROADSTER pivotal and extended-access cohorts shows excellent 1-year durability of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2019 Jun;69(6):1786-1796. doi: 10.1016/j.jvs.2018.08.179. Epub 2019 Jan 2.
PubMed 30611582
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION of FLOW ALTERED, SHORT TRANSCERVICAL CAROTID ARTERY STENTING in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE With Filter.
- ClinicalTrials.gov ID
- NCT01685567
- Acronym / sponsor ID
- ROADSTER / SRM-2012-02
- Conditions
- Carotid Artery Disease
- Keywords
- carotid artery disease, reverse flow
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Silk Road MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MICHI NPS+f | Experimental | Device: MICHI NPS+fThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
- Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
- Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
- Patient is greater or equal to 18 years of age.
- Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
Key exclusion criteria (34 listed)
- Patient has chronic atrial fibrillation.
- Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
- Patient has an evolving stroke.
- Patient has severe dementia.
- Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICHI NPS+fAlso: ENROUTE Transcarotid Neuroprotection SystemCerebral protection with carotid flow reversal | Device | MICHI NPS+f |
Primary outcome
Hierarchical Composite of Stroke, Myocardial Infarction, and Death
Time frame: 30-day post-procedure
The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.
4 secondary outcomes
All Death (Non-hierarchical)
Time frame: 0 to 30 days
All Myocardial Infarctions (Non-hierarchical)
Time frame: 0 to 30 days
All Stroke (Non-hierarchical)
Time frame: 0 to 30 days
Ipsilateral Stroke (Non-hierarchical)
Time frame: 31-365 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26506270Kwolek CJ, Jaff MR, Leal JI, Hopkins LN, Shah RM, Hanover TM, Macdonald S, Cambria RP. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015 Nov;62(5):1227-34. doi: 10.1016/j.jvs.2015.04.460.
- Results publication: PubMed 28335706Alpaslan A, Wintermark M, Pinter L, Macdonald S, Ruedy R, Kolvenbach R. Transcarotid Artery Revascularization With Flow Reversal. J Endovasc Ther. 2017 Apr;24(2):265-270. doi: 10.1177/1526602817693607. Epub 2017 Feb 17.
- Derived from this study: PubMed 36563712Chung J, Kumins NH, Smith J, Motaganahalli RL, Schneider PA, Kwolek CJ, Kashyap VS; ROADSTER Investigators. Physiologic risk factors increase risk of myocardial infarction with transcarotid artery revascularization in prospective trials. J Vasc Surg. 2023 Apr;77(4):1192-1198. doi: 10.1016/j.jvs.2022.12.013. Epub 2022 Dec 20.
- Derived from this study: PubMed 30611582Malas MB, Leal Lorenzo JI, Nejim B, Hanover TM, Mehta M, Kashyap V, Kwolek CJ, Cambria R. Analysis of the ROADSTER pivotal and extended-access cohorts shows excellent 1-year durability of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2019 Jun;69(6):1786-1796. doi: 10.1016/j.jvs.2018.08.179. Epub 2019 Jan 2.
- Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.Link provided by the sponsor.
- Transcarotid Artery Revascularization with Flow Reversal: the PROOF StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Kwolek, MD principal investigator
Massachusetts General Hospital
Richard Cambria, MD principal investigator
Massachusetts General Hospital
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MICHI NPS+f in people with Carotid Artery Disease, run by Silk Road Medical at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical Composite of Stroke, Myocardial Infarction, and Death (time frame: 30-day post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01685567, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017; AzTrials last refreshed its copy on 30 Oct 2026.