Carotid Artery DiseaseNCT02536378
POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
An observational study of Carotid Artery Disease, run by Silk Road Medical at 43 sites in 3 countries.
Trial summary
The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease
- How many people
- 692 participants
- Where
- 43 sitesin 3 countries
- Study dates
- 23 Oct 2015to 29 Apr 2019
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
Study population: Patients with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography to be: * Symptomatic: greater than or equal to 50% stenosis or * Asymptomatic: greater than or equal to 80% stenosis
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 >50% as determined by an angiogram and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure procedure ipsilateral to the carotid artery to be stented.
- OR Asymptomatic: Stenosis must be >80% as determined by angiogram without any neurological symptoms within the prior 180 days.
- Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for 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 ≥18 years of age.
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- 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 Institutional 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 must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention.
- Patient meets at least one of the surgical high-risk criteria listed below.
- Anatomic High Risk Inclusion Criteria:
- Contralateral carotid artery occlusion B. Tandem stenoses >70% C. High cervical carotid artery stenosis D. Restenosis after carotid endarterectomy E. Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment.
- Hostile Necks which the Investigator deems safe for transcarotid access including but not limited to:
- Prior neck irradiation II. Radical neck dissection III. Cervical spine immobility
- Clinical High Risk Inclusion Criteria:
- Patient is > 75 years of age H. Patient has > 2-vessel coronary artery disease and history of angina of any severity I. Patient has a history of angina
- Canadian Cardiovascular Society (CCS) angina class 3 or 4 or
- unstable angina
- Patient has congestive heart failure (CHF) - New York Heart Association (NYHA)
- Functional Class III or IV
- Patient has known severe left ventricular dysfunction
- LVEF <30%.
- Patient has had a myocardial infarction > 72 hours and < 6 weeks prior to procedure.
- Patient has severe pulmonary disease (COPD) with either:
- FEV1 <50% predicted or
- chronic oxygen therapy or
- resting PO2 of <60 mmHg (room air)
- Patient has permanent contralateral cranial nerve injury O. Patient has chronic renal insufficiency (serum creatinine > 2.5 mg/dL).
- REMINDER: The following is a list of anatomical considerations that are not suitable for transfemoral CAS with distal protection that are NOT contraindications for enrollment in the ROADSTER 2 Study including but not limited to:
- TypeII, III, or Bovine arch II. Arch atheroma or calcification III. Atheroma of the great vessel origins IV. Tortuous distal ICA V. Tortuous or occluded iliofemoral segments VI. Occluded aortoiliac segments
Who cannot join
- Each potential patient must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.
- Patient has an alternative source of cerebral embolus, including but not limited to:
- 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.
- 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.
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- Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA ≤ 6 months prior to index procedure) 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 a history of spontaneous intracranial hemorrhage within the past 12 months, or 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.
- Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
- Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.
- Patient has an intracranial tumor.
- Patient has an evolving stroke.
- Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, 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, or intracranial hemorrhage).
- Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.
- Patient has an isolated hemisphere.
- Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.
- Myocardial Infarction within 72 hours prior to the intervention.
- Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.
- Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
- 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) whether or not it is associated with an ulcerated target lesion.
- Ostium of Common Carotid Artery (CCA) requires revascularization.
- Patient has an open stoma in the neck.
- Female patients who are pregnant or may become pregnant.
- 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, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel.
- Patient must have a life expectancy <3 years without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score and patients with primary, recurrent or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
Trial locations and contacts
43 sites in 3 countries.
43 sites in 3 countries
United States41 sites
Albany Medical Center
Albany, New York, 12208
New Mexico
Albuquerque, New Mexico, 87102
Emory Healthcare
Atlanta, Georgia, 30322
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
John Hopkins
Baltimore, Maryland, 21224
Eastern Maine Medical Center
Bangor, Maine, 04401
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18018
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel
Boston, Massachusetts, 02215
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Sisters of Charity Hospital
Buffalo, New York, 14214
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
Carolinas Medical Center
Charlotte, North Carolina, 28203
Sentara Vascular Specialists
Chesapeake, Virginia, 23320
University Hospitals Case Medical Center and Case Western Reserve University School of Medicine
Cleveland, Ohio, 44106
Unity Point Health - Iowa Clinic
Des Moines, Iowa, 50309
Michigan Vascular Center
Flint, Michigan, 48507
Greenville Hospital System
Greenville, South Carolina, 29605
Kaiser Permanente, Hawaii
Honolulu, Hawaii, 96819
Houston Methodist DeBakey Heart & Vascular Center
Houston, Texas, 77030
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Dartmouth Hitchcock Medical Ct.
Lebanon, New Hampshire, 03756
Peter Morton UCLA Medical Center
Los Angeles, California, 90095
Baptist Health Louisville
Louisville, Kentucky, 40207
University of Wisconsin
Madison, Wisconsin, 53792
Abbott Northwestern
Minneapolis, Minnesota, 55407
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
New Your Presbytarian - Weill Cornell
New York, New York, 10065
Oklahoma Heart
Oklahoma City, Oklahoma, 73120
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
UPMC (University of Pittsburgh Medical Center)
Pittsburgh, Pennsylvania, 15213
University of Rochester
Rochester, New York, 14623
Virginia Mason Medical Center
Seattle, Washington, 98101
Washington University School of Medicine
St Louis, Missouri, 63110
Stony Brook Medicine
Stony Brook, New York, 11794
Scott and White Memorial Hospital
Temple, Texas, 76508
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE. The ROADSTER 2 Study.
The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.
- Conditions
- Carotid Artery Disease
- Medical subject headings
- Carotid Artery Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedural Success
Procedural success is defined as acute device success (successful insertion of the ENROUTE NPS and establishment of flow reversal), technical success (deployment of interventional tools) and the absence of a major adverse events (hierarchical stroke/death/myocardial infarction) through 30 days.
Measured: 30 Days
Secondary outcomes (4)
Number of Participants Experiencing Major Adverse Event
Secondary endpoints include the 30-day rate of hierarchical stroke, death or myocardial infarction, the rate of hierarchical stroke, death or myocardial infarction by symptom status, the rate of cardiac death and the rate of neurological death.
Measured: 30 days
Number of Participants With Acute Device Success
Acute device success is defined as the ability to insert the device, establish flow reversal, and remove the device
Measured: 2 hours (periprocedural)
Number of Participants With Technical Success
Technical success is defined as acute device success plus the ability to deliver interventional tools
Measured: 2 hours (periprocedural)
Number of Participants in Which a Cranial Nerve Injury Occurred
Rate of cranial nerve injury suspected to be caused by surgical procedure and adjudicated by CEC.
Measured: 90 days (extended follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study start23 Oct 2015
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 692 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Silk Road Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikram Kashyap, MD, Principal investigator, University Hospital Case Medical Center Harrington Heart & Vascular InstitutePeter Schneider, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536378
- Sponsor's protocol ID
- SRM-2015-02
- Status last verified
- Jul 2020
- First submitted
- 27 Aug 2015
- Last updated
- 29 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Alpaslan 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 36563712Kashyap VS, So KL, Schneider PA, Rathore R, Pham T, Motaganahalli RL, Massop DW, Foteh MI, Eckstein HH, Jim J, Leal Lorenzo JI, Melton JG. One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial. J Vasc Surg. 2022 Aug;76(2):466-473.e1. doi: 10.1016/j.jvs.2022.03.872. Epub 2022 Apr 2.
PubMed 35381327Kashyap VS, Schneider PA, Foteh M, Motaganahalli R, Shah R, Eckstein HH, Henao S, LaMuraglia G, Stoner MC, Melton J, Massop D, Hanover T, Titus J, Moore WS, Rodriguez-Carvajal R, Malas MB, Arko FR 3rd, Pierce D, Anain P, Oskin T; ROADSTER 2 Investigators*. Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease. Stroke. 2020 Sep;51(9):2620-2629. doi: 10.1161/STROKEAHA.120.030550. Epub 2020 Aug 19.
PubMed 32811386
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE. The ROADSTER 2 Study.
- ClinicalTrials.gov ID
- NCT02536378
- Acronym / sponsor ID
- SRM-2015-02
- Conditions
- Carotid Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- Silk Road MedicalIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Posted 29 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography to be: * Symptomatic: greater than or equal to 50% stenosis or * Asymptomatic: greater than or equal to 80% stenosis
Key inclusion criteria (30 listed)
- Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
- Symptomatic: Stenosis must be >50% as determined by an angiogram and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure procedure ipsilateral to the carotid artery to be stented.
- OR Asymptomatic: Stenosis must be >80% as determined by angiogram without any neurological symptoms within the prior 180 days.
- Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements).
- Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
Key exclusion criteria (25 listed)
- Each potential patient must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.
- Patient has an alternative source of cerebral embolus, including but not limited to:
- Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or 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.
- Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
- Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Procedural Success
Time frame: 30 Days
Procedural success is defined as acute device success (successful insertion of the ENROUTE NPS and establishment of flow reversal), technical success (deployment of interventional tools) and the absence of a major adverse events (hierarchical stroke/death/myocardial infarction) through 30 days.
4 secondary outcomes
Number of Participants Experiencing Major Adverse Event
Time frame: 30 days
Number of Participants With Acute Device Success
Time frame: 2 hours (periprocedural)
Number of Participants With Technical Success
Time frame: 2 hours (periprocedural)
Number of Participants in Which a Cranial Nerve Injury Occurred
Time frame: 90 days (extended follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 35381327Kashyap VS, So KL, Schneider PA, Rathore R, Pham T, Motaganahalli RL, Massop DW, Foteh MI, Eckstein HH, Jim J, Leal Lorenzo JI, Melton JG. One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial. J Vasc Surg. 2022 Aug;76(2):466-473.e1. doi: 10.1016/j.jvs.2022.03.872. Epub 2022 Apr 2.
- Derived from this study: PubMed 32811386Kashyap VS, Schneider PA, Foteh M, Motaganahalli R, Shah R, Eckstein HH, Henao S, LaMuraglia G, Stoner MC, Melton J, Massop D, Hanover T, Titus J, Moore WS, Rodriguez-Carvajal R, Malas MB, Arko FR 3rd, Pierce D, Anain P, Oskin T; ROADSTER 2 Investigators*. Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease. Stroke. 2020 Sep;51(9):2620-2629. doi: 10.1161/STROKEAHA.120.030550. Epub 2020 Aug 19.
- 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.
Vikram Kashyap, MD principal investigator
University Hospital Case Medical Center Harrington Heart & Vascular Institute
Peter Schneider, MD principal investigator
Kaiser Permanente
43 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Disease, run by Silk Road Medical at 43 sites in 3 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 30 inclusion and 25 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2020). 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?
Number of Participants With Procedural Success (time frame: 30 Days). 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 NCT02536378, 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 29 Jul 2020.