SVS VQI TransCarotid Revascularization Surveillance Project (VQI-TCAR)

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ClinicalTrials.gov Identifier: NCT02850588

Recruitment Status : Recruiting

First Posted : August 1, 2016

Last Update Posted : October 31, 2018

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Sponsor:

Information provided by (Responsible Party):

Society for Vascular Surgery Patient Safety Organization

Study Description

Brief Summary:

The VQI TCAR Surveillance Project is designed to monitor the safety and effectiveness of stents placed directly into the carotid artery while reversing blood flow within the carotid artery to reduce stroke risk. It will compare this less-invasive surgical procedure with standard carotid endarterectomy in centers that participate in the Society for Vascular Surgery Vascular Quality Initiative.

Condition or disease	Intervention/treatment
Carotid Artery Disease	Procedure: Transcarotid artery revascularization Procedure: Carotid endarterectomy

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Study Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	15000 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Target Follow-Up Duration:	1 Year
Official Title:	TransCarotid Revascularization Surveillance Project of the Society for Vascular Surgery Vascular Quality Initiative
Actual Study Start Date :	November 1, 2016
Estimated Primary Completion Date :	December 2024
Estimated Study Completion Date :	December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Carotid Artery Disease

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
TCAR treatment All high risk surgical patients undergoing transcarotid revascularization with a carotid stent during carotid artery flow reversal in hospitals that participate in the Carotid Artery Stent Registry of the Society for Vascular Surgery Patient Safety Organization	Procedure: Transcarotid artery revascularization Direct implantation of a stent into the carotid artery via a surgical incision in the neck combined with blood flow reversal in the carotid artery during stent placement
CEA treatment All patients undergoing carotid endarterectomy in hospitals that participate in the Carotid Endarterectomy Registry of the Society for Vascular Surgery Patient Safety Organization	Procedure: Carotid endarterectomy Removal of carotid atherosclerotic plaque (endarterectomy) via a surgical incision in the neck

Outcome Measures

Primary Outcome Measures :

One-year ipsilateral stroke or death [ Time Frame: 1 year ]
Any death or stroke in the territory of the treated carotid artery within one year of the carotid artery treatment

Secondary Outcome Measures :

30-day Stroke or death [ Time Frame: 30 days ]
Any stroke or death within 30 days of the carotid artery treatment
30-day Stroke, death or myocardial infarction [ Time Frame: 30 days ]
Any stroke, death or myocardial infarction within 30 days of the carotid artery treatment

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

High surgical risk patients who undergo TCAR and CEA in hospitals participating in the CAS or CEA registries of the SVS PSO

Criteria

Inclusion Criteria:

Patients undergoing TCAR or CEA who are considered high surgical risk as defined by the CMS criteria published in the National Coverage Determination for Percutaneous Transluminal Angioplasty (20.7). Any of the following criteria qualify a patient for inclusion in the high surgical risk TCAR or CEA cohort:

Anatomic High Risk Inclusion Criteria:

Contralateral carotid artery occlusion
Tandem stenoses >70%
High cervical carotid artery stenosis
Restenosis after carotid endarterectomy
Bilateral carotid artery stenosis requiring treatment
Hostile neck which the Investigator deems safe for transcarotid access including but not limited to prior neck irradiation, prior radical neck dissection or cervical spine immobility

Clinical High Risk Inclusion Criteria:

Patient is >= 75 years of age
Patient has >= 2-vessel coronary artery disease and history of angina of any severity
Patient has a history of unstable angina or Canadian Cardiovascular Society (CCS) angina class 3 or 4
Patient has congestive heart failure (CHF) - New York Heart Association (NYHA) Functional Class III or IV
Patient has known severe left ventricular dysfunction with 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 (on room air)
Patient has permanent contralateral cranial nerve injury
Patient has chronic renal insufficiency (serum creatinine > 2.5 mg/dL).

Exclusion Criteria:

Patients undergoing TCAR or CEA who do not meet at least one of the above inclusion criteria, plus patients who have received a previous stent in the target artery.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850588

Contacts

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Contact: James Wadzinski	312-334-2311	jwadzinski@svspso.org

Locations

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United States, Illinois
Society for Vascular Surgery Patient Safety Organization	Recruiting
Chicago, Illinois, United States, 60611
Contact: JAMES K Wadzinski 312-334-2311 jwadzinski@svspso.org

Sponsors and Collaborators

Society for Vascular Surgery Patient Safety Organization

Investigators

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Study Chair:	Marc L Schermerhorn, MD	Society for Vascular Surgery Patient Safety Organization

More Information

Additional Information:

Publications:

Schermerhorn ML, Fokkema M, Goodney P, Dillavou ED, Jim J, Kenwood CT, Siami FS, White RA; SVS Outcomes Committee. The impact of Centers for Medicare and Medicaid Services high-risk criteria on outcome after carotid endarterectomy and carotid artery stenting in the SVS Vascular Registry. J Vasc Surg. 2013 May;57(5):1318-24. doi: 10.1016/j.jvs.2012.10.107. Epub 2013 Feb 11.

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.

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Responsible Party:	Society for Vascular Surgery Patient Safety Organization
ClinicalTrials.gov Identifier:	NCT02850588 History of Changes
Other Study ID Numbers:	VQI TCAR
First Posted:	August 1, 2016 Key Record Dates
Last Update Posted:	October 31, 2018
Last Verified:	October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

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Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

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