SVS VQI TransCarotid Revascularization Surveillance Project (VQI-TCAR)

• ClinicalTrials.gov Identifier: NCT02850588
• Recruitment Status: Recruiting
• First Posted: August 1, 2016
• Last Update Posted: March 24, 2020
• Sponsor: Society for Vascular Surgery Patient Safety Organization
• 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

Detailed Description:

Background:

Contemporary randomized trials of transfemoral carotid artery stenting (TF CAS) and carotid endarterectomy (CEA) have shown comparable long-term ipsilateral stroke prevention (>30 days) but have consistently demonstrated higher periprocedural (< 30 day) stroke rates, including contralateral stroke, compared with CEA, with the highest risk centered around "day zero". Potential etiologies for this excess risk likely relate to embolization during unprotected catheterization of the aortic arch and supraaortic vessels from a TF approach and/or suboptimal distal embolic protection during CAS. TransCarotid Artery Revascularization (TCAR) combines the surgical principles of neuroprotection with minimally invasive endovascular techniques to treat stenosis in the carotid artery. It involves surgical exposure and clamping of the proximal common carotid artery with continuous carotid blood flow reversal via an extracorporeal arteriovenous shunt from the target carotid artery to a femoral vein, during which carotid bifurcation/internal carotid artery stenting is performed. Thus, TCAR avoids catheter manipulation in the aortic arch and emulates the "clamp and backbleed" method of neuroprotection during CEA, but differs from CEA in that the carotid artery is accessed through a smaller, supra-clavicular incision below the main plexus of cranial nerves. Further, the direct transcarotid approach allows the use of larger bore sheaths and tubing to achieve higher reverse carotid artery flow rates than is possible with smaller transfemoral catheters.

Published TCAR Data:

The initial study of TCAR in patients deemed to be at high risk for complications from CEA have shown that TCAR appears to provide superior stroke and death outcomes when compared to prior registry results from both CEA and TF CAS. Schermerhorn, et al reported outcomes from the Society for Vascular Surgery (SVS) Vascular Registry in high surgical risk patients and found that in this real world registry, the 30-day stroke and death rates in symptomatic patients for CEA and TF CAS were 6.4% and 7.9% respectively. (Citation: Schermerhorn) In asymptomatic, high risk patients, the 30-day stroke and death rates for CEA and TF CAS were 3.7% and 4.8% respectively. In contrast, a recent study of TCAR (ROADSTER pivotal trial) , the 30-day stroke and death rates for both symptomatic and asymptomatic patients were 2.8% and 2.9%, respectively. (Citation: Kwolek) While these initial results of TCAR are encouraging, they involved only 114 patients in the pivotal trial, such that further evaluation is clearly important.

Objective:

The objective of the VQI TransCarotid Artery Revascularization Surveillance Project is to evaluate the safety and effectiveness of TCAR in real world practice, using a contemporaneous comparison with CEA. Stroke and death outcomes data in TCAR and CEA patients deemed to be at high risk for complications from CEA will be collected and analyzed using the SVS PSO CAS and CEA Registries. High surgical risk is defined according to the CMS criteria published in the National Coverage Determination for Percutaneous Transluminal Angioplasty (20.7) and listed in the inclusion criteria. The evaluation of these alternate strategies for surgical treatment of carotid artery disease is central to the mission of the SVS PSO.

Methods:

All high surgical risk patients treated with TCAR and CEA in the SVS PSO CAS and CEA Registries will be included and separately analyzed as symptomatic and asymptomatic, with symptomatic defined as a history of ipsilateral stroke, TIA and/or amaurosis fugax within 180 days of the procedure. 30-day and one-year outcomes will be analyzed in propensity matched, risk adjusted cohorts. Any FDA-cleared proximal embolic protection device and FDA-approved carotid artery stent system indicated for the transcarotid approach will be included in the registry. Sites participating in VQI are audited for consecutive case submission by comparison with claims data. A Steering Committee within the SVS PSO will monitor the quality and completeness of submitted data, and adjudicate any questionable outcomes by querying sites for clarifying information. This committee will be responsible for scientific analysis and periodic publication of the results.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 20000 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

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 :

1. 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 :

1. 30-day Stroke or death [ Time Frame: 30 days ]
   Any stroke or death within 30 days of the carotid artery treatment
2. 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

• 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

Contacts

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

Locations

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

• 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.

• Responsible Party: Society for Vascular Surgery Patient Safety Organization
• ClinicalTrials.gov Identifier: NCT02850588
• Other Study ID Numbers: VQI TCAR
• First Posted: August 1, 2016
• Last Update Posted: March 24, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

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