POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:September 2015
End Date:January 2019
Contact:Linda Ruedy
Email:lruedy@silkroadmed.com
Phone:408-585-2113

Use our guide to learn which trials are right for you!

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.


INCLUSION CRITERIA:

1. 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.

2. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection
System and ENROUTE Stent System (refer to IFU for 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 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.

6. Patient is willing to comply with the protocol requirements and return to the
treatment center for all required clinical evaluations.

7. 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.

8. Patient meets at least one of the surgical high-risk criteria listed below.

Anatomic High Risk Inclusion Criteria:

A. 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.

F. Hostile Necks which the Investigator deems safe for transcarotid access including but
not limited to:

I. Prior neck irradiation II. Radical neck dissection III. Cervical spine immobility

Clinical High Risk Inclusion Criteria:

G. 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

J. Patient has congestive heart failure (CHF) - New York Heart Association (NYHA)

- Functional Class III or IV

K. Patient has known severe left ventricular dysfunction

- LVEF <30%.

L. Patient has had a myocardial infarction > 72 hours and < 6 weeks prior to procedure.

M. Patient has severe pulmonary disease (COPD) with either:

- FEV1 <50% predicted or

- chronic oxygen therapy or

- resting PO2 of <60 mmHg (room air)

N. 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:

I. 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

EXCLUSION CRITERIA:

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.

1. Patient has an alternative source of cerebral embolus, including but not limited to:

1. Patient has chronic atrial fibrillation.

2. Patient has had any episode of paroxysmal atrial fibrillation within the past 6
months, or history of paroxysmal atrial fibrillation requiring chronic
anticoagulation.

3. 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).

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

5. 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.

2. 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.

3. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.

4. 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.

5. Patient has an intracranial tumor.

6. Patient has an evolving stroke.

7. 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).

8. Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.

9. Patient has an isolated hemisphere.

10. Patient had or will have CABG, endovascular stent procedure, valve intervention or
vascular surgery within 30 days before or after the intervention.

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

12. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA
or significant CCA inflow lesion.

13. Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm
of the ipsilateral common or internal carotid artery.

14. 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.

15. Ostium of Common Carotid Artery (CCA) requires revascularization.

16. Patient has an open stoma in the neck.

17. Female patients who are pregnant or may become pregnant.

18. 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.

19. 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.
We found this trial at
42
sites
Albany, New York 12208
Principal Investigator: Sean Roddy, MD
Phone: 518-262-1409
?
mi
from
Albany, NY
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Glenn LaMuraglia, MD
Phone: 617-643-2731
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Mark Farber, MD
Phone: 919-843-1279
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Frank Arko, MD
Phone: 704-355-4794
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Michael Stoner, MD
Phone: 585-276-1739
University of Rochester The University of Rochester is one of the country's top-tier research universities....
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Albuquerque, New Mexico
Principal Investigator: Steven A Henao, MD
Phone: 505-843-2871
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Atlanta, Georgia 30322
Principal Investigator: Joseph Zarge, MD
Phone: 678-843-6092
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78756
Principal Investigator: Mazin Foteh, MD
Phone: 512-459-3300
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21287
Principal Investigator: Mahmoud Malas, MD
Phone: 410-550-4395
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Frank Flanagan, MD
Phone: 207-973-7224
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Bethlehem, Pennsylvania
Principal Investigator: Timothy Oskin, MD
Phone: 484-526-7825
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Boston, Massachusetts
Principal Investigator: Marc Schermerhorn, MD
Phone: 617-632-7488
?
mi
from
Boston, MA
Click here to add this to my saved trials
Brighton, Massachusetts 02135
Principal Investigator: Nikhil Kansal, MD
Phone: 617-789-2225
?
mi
from
Brighton, MA
Click here to add this to my saved trials
Buffalo, New York 14214
Principal Investigator: Paul Anain, MD
Phone: 727-828-3680
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Charleston, West Virginia 25304
Principal Investigator: Ali AbuRahama, MD
Phone: 304-388-9679
?
mi
from
Charleston, WV
Click here to add this to my saved trials
Chesapeake, Virginia 23320
Principal Investigator: Rasesh Shah, MD
Phone: 757-388-5625
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
Cleveland, Ohio 44106
Principal Investigator: Vikram Kashyap, MD
Phone: 216-844-2988
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Des Moines, Iowa 50309
Principal Investigator: Douglas Massop, MD
Phone: 515-241-6757
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Flint, Michigan 98507
Principal Investigator: Robert Molnar, MD
Phone: 810-600-2009
?
mi
from
Flint, MI
Click here to add this to my saved trials
Greenville, South Carolina 29615
Principal Investigator: Tod Hanover, MD
Phone: 864-454-8293
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Honolulu, Hawaii 96819
Principal Investigator: Peter Schneider, MD
Phone: 808-432-5555
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Alan Lumsden, MD
Phone: 713-441-6537
?
mi
from
Houston, TX
Click here to add this to my saved trials
2002 Holcombe Blvd
Houston, Texas 77030
(713) 791-1414
Principal Investigator: Panagiotis Kougias, MD
Phone: 713-791-1414
Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Raghu Motaganahalli, MD
Phone: 317-962-0287
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kingsport, Tennessee 37660
Principal Investigator: Christopher Metzger, MD
Phone: 423-230-5643
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
36 Lahaye Drive
Lebanon, New Hampshire 03756
Principal Investigator: Richard Powell, MD
Phone: 603-650-7966
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Los Angeles, California 90095
Principal Investigator: Wesley Moore, MD
Phone: 310-206-1115
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
Principal Investigator: Brad Thomas, MD
Phone: 502-638-5124
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Paul DiMusto, MD
Phone: 608-265-6648
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
Principal Investigator: Jessica Titus, MD
Phone: 612-863-3793
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
21 Arcisstraße
Munich, 81675
Principal Investigator: Hans-Henning Eckstein, MD
?
mi
from
Munich,
Click here to add this to my saved trials
525 East 68th Street
New York, New York 10065
Principal Investigator: Darren Schneider, MD
Phone: 646-962-8400
?
mi
from
New York, NY
Click here to add this to my saved trials
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Peter Faries, MD
Phone: 212-241-8250
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
mi
from
New York, NY
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Virendra Patel, MD
Phone: 212-342-4102
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73120
Principal Investigator: Jim Melton, DO
Phone: 405-628-6288
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Paul Dimuzio, MD
Phone: 215-955-8184
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3459 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Rabih Chaer, MD
Phone: 412-623-8452
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Sean J English, MD
Phone: 314-747-7828
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Damon Pierce, MD
Phone: 206-342-6976
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Stony Brook, New York 11794
Principal Investigator: Angela Kokkosis, MD
Phone: 631-444-1790
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Principal Investigator: William Bohannon, MD
Phone: 254-724-5814
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
?
mi
from
Temple, TX
Click here to add this to my saved trials
Washington, District of Columbia
Principal Investigator: Edward Woo, MD
Phone: 202-877-8475
?
mi
from
Washington,
Click here to add this to my saved trials