Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease

Carotid Artery Diseases Clinical Trial

Official title:

Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease. The ROADSTER 3 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365490
• Other study ID #: SRM-2022-01
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: May 2025

Study information

• Verified date: August 2023
• Source: Silk Road Medical
• Contact: Dipti Sahoo
• Phone: 669-271-0501
• Email: dsahoo[@]silkroadmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy

Description:

This is an open label, single arm, multi-center post-approval study for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and who are eligible for treatment using the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System. The study will enroll a maximum of 400 patients treated per protocol at 30-60 sites in the United States.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography.

2. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: =70% stenosis of the common or internal carotid artery by ultrasound or =50% stenosis of the common or internal carotid artery by angiogram OR Asymptomatic: =70% stenosis of the common or internal carotid artery by ultrasound or =60% stenosis of the common or internal carotid artery by angiogram

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

4. Patient is =18 and <80 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 of the respective clinical site prior to the study 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.

Exclusion Criteria:

1. Patient meets any of the surgical high-risk criteria listed below.

1. Anatomic high risk exclusion criteria:

• Contralateral carotid artery occlusion
• Tandem stenoses in the ICA >70% diameter reducing
• High cervical carotid artery stenosis above the C2 vertebra
• Restenosis after prior ipsilateral carotid endarterectomy
• Bilateral carotid artery stenosis requiring treatment within 30 days after index procedure
• Hostile Necks including prior neck irradiation, radical neck dissection, and cervical spine immobility

2. Clinical high risk exclusion criteria:

• Patient is =80 years of age
• Patient has =2-vessel coronary artery disease (or has had revascularization procedure within the last 30 days) and/or angina
• Patient has history of unresolved 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 a known severe left ventricular dysfunction - LVEF <30%
• Patient has had a myocardial infarction within 6 weeks prior to the procedure
• Patient has severe obstructive pulmonary disease (COPD) with either:
• FEVI <50% predicted OR
• chronic oxygen therapy OR
• resting PO2 of =60 mmHG (room air)
• Patient has permanent contralateral cranial and/or laryngeal nerve injury
• Patient has chronic renal insufficiency (serum creatinine =2.5 mg/dL) or is on dialysis

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

1. Chronic atrial fibrillation.

2. 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 thrombus. (If patient has 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 AND there is no confirmed thrombus on an echocardiogram performed within 3 months prior to index procedure, the patient may be eligible for enrollment).

4. Recently implanted heart valve (either surgically or endovascularly) within 60 days prior to index procedure with confirmed emboli on echocardiogram.

5. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by pre-procedure 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.

3. 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.

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

5. Patient with a history of major stroke prior to the TCAR procedure attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS =5 OR mRS =3) likely to confound study endpoints 1 month after the TCAR procedure (because the deficit persists post-operatively).

6. Patient has an intracranial tumor.

7. Patient has an evolving stroke.

8. Patient has neurologic illnesses within the past 2 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.

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

10. Patient has an isolated hemisphere

11. Patient had or will have open heart (e.g., CABG), endovascular stent procedure, valve intervention, vascular surgery, other major operation within 30 days of the index procedure.

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 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 ENROUTE stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, statin or contrast media (that cannot be pre-medicated). Patients must be able to tolerate statins (or a permitted non-statin substitute) and a combination of ASA and ticlopidine or ASA and clopidogrel or alternative P2Y12 inhibitor..

19. Patient has a life expectancy <5 years without contingencies related to other medical, surgical, or interventional procedures or is at High Risk as per the Wallaert Score. Estimation of life expectancy and scoring per the Wallaert Score is to be performed prior to enrollment.

20. Patient has primary, recurrent or metastatic malignancy and does not have independent assessment of life expectancy of =5 years performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.

21. Patient has an unresolved/uncorrected bleeding disorder.

22. Patient has a known allergy to nitinol

23. Patient is known to have an active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or has been previously diagnosed with COVID-19 with neurological sequelae that could confound endpoint assessments (e.g., baseline mRS>3).

Related Conditions & MeSH terms

• Carotid Artery Diseases

Intervention

Procedure:
• Transcarotid Artery Revascularization (TCAR)
Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent

Locations

Country	Name	City	State
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	Baton Rouge General	Baton Rouge	Louisiana
United States	McLaren Heart & Vascular	Bay City	Michigan
United States	St. Charles Health System	Bend	Oregon
United States	St. Luke's University Hospital	Bethlehem	Pennsylvania
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	CAMC	Charleston	West Virginia
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Atrium Health	Charlotte	North Carolina
United States	St. Luke's Hospital	Chesterfield	Missouri
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Northside Vascular	Cumming	Georgia
United States	Baylor Scott & White Dallas	Dallas	Texas
United States	Delray Medical Center	Delray Beach	Florida
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Deaconess Research / Evansville Surgical Associates	Evansville	Indiana
United States	Corewell Health	Grand Rapids	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	UPMC Pinnacle	Harrisburg	Pennsylvania
United States	Memorial Hermann Southeast	Houston	Texas
United States	Valley Vascular Consultants	Huntsville	Alabama
United States	Indiana University	Indianapolis	Indiana
United States	University of California, San Diego (UCSD)	La Jolla	California
United States	Sharp Grossmont	La Mesa	California
United States	Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital	Lafayette	Louisiana
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of California, Los Angeles (UCLA)	Los Angeles	California
United States	Cardiovascular Surgery Clinic	Memphis	Tennessee
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Abbott Northwestern	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	New York University	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	Sentara	Norfolk	Virginia
United States	Midwest Aortic & Vascular Institute	North Kansas City	Missouri
United States	AdventHealth Ocala	Ocala	Florida
United States	Coastal Vascular & Interventional	Pensacola	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Baylor Scott & White Plano	Plano	Texas
United States	Maine Medical Center	Portland	Maine
United States	Providence St. Vincent	Portland	Oregon
United States	Duke University	Raleigh	North Carolina
United States	Carilion Roanoke Memorial	Roanoke	Virginia
United States	University of Rochester	Rochester	New York
United States	University of California, San Francisco (UCSF)	San Francisco	California
United States	HonorHealth	Scottsdale	Arizona
United States	Houston Methodist Sugarland	Sugar Land	Texas
United States	Pima Heart & Vascular	Tucson	Arizona
United States	Carle Health	Urbana	Illinois
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Silk Road Medical

Country where clinical trial is conducted

United States, 

References & Publications (3)

Malas MB, Dakour-Aridi H, Kashyap VS, Eldrup-Jorgensen J, Wang GJ, Motaganahalli RL, Cronenwett JL, Schermerhorn ML. TransCarotid Revascularization With Dynamic Flow Reversal Versus Carotid Endarterectomy in the Vascular Quality Initiative Surveillance Pr — View Citation

Schermerhorn ML, Liang P, Eldrup-Jorgensen J, Cronenwett JL, Nolan BW, Kashyap VS, Wang GJ, Motaganahalli RL, Malas MB. Association of Transcarotid Artery Revascularization vs Transfemoral Carotid Artery Stenting With Stroke or Death Among Patients With C — View Citation

Vilain KR, Magnuson EA, Li H, Clark WM, Begg RJ, Sam AD 2nd, Sternbergh WC 3rd, Weaver FA, Gray WA, Voeks JH, Brott TG, Cohen DJ; CREST Investigators. Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at standard surgical risk: results from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2012 Sep;43(9):2408-16. doi: 10.1161/STROKEAHA.112.661355. Epub 2012 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hierarchical composite of Major Adverse Events (MAEs)	Hierarchical composite of Major Adverse Events (MAEs) defined as any death, stroke, or myocardial infarction within 30 days of the index procedure	within 30 days of the index procedure
Primary	Ipsilateral Stroke	Ipsilateral stroke within 31 days to 365 days following the index procedure	within 31 to 365 days following the index procedure
Secondary	Incidence of cranial nerve injury	Incidence of cranial nerve injury within 30 days of the index procedure	within 30 days of the index procedure
Secondary	Stroke	Stroke within 30 days of the index procedure	within 30 days of the index procedure
Secondary	Death	Death within 30 days of the index procedure	within 30 days of the index procedure
Secondary	MI	MI within 30 days of the index procedure	within 30 days of the index procedure
Secondary	Stroke/Death/MI	Stroke/Death/MI within 30 days of the index procedure	within 30 days of the index procedure
Secondary	Ipsilateral Stroke	Ipsilateral stroke within 31 to 365 days of the index procedure	31-365 days
Secondary	Persistent cranial nerve injury	Persistent cranial nerve injury at 6 months and 1 year	at 6 months and 1 year
Secondary	Rate of hierarchical ipsilateral stroke, death, and myocardial infarction	Rate of hierarchical ipsilateral stroke, death, and myocardial infarction within 30 days of the index procedure	within 30 days of the index procedure
Secondary	Cardiac death	Cardiac death at 1 year for patients who experienced an MI within 30 days of the index procedure	1 year
Secondary	Access site complications	Access site complications (arterial/venous)	within 30 days of the index procedure
Secondary	Serious Hematoma/Bleeding complications	Serious Hematoma/Bleeding complications (arterial/venous)	within 30 days of the index procedure
Secondary	Rate of stent thrombosis or occlusion	Rate of stent thrombosis or occlusion within 30 days of the index procedure	within 30 days of the index procedure
Secondary	Rate of dissection	Rate of dissection within 30 days of the index procedure (during index procedure or a reintervention procedure)	within 30 days of the index procedure

External Links

•   Description: Peri-procedural Outcomes After Carotid Artery Stenting with the First 15,000 Patients Enrolled in the SAPPHIRE Worldwide Study.