NCT02850588

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Nov 2016Dec 2027

First Submitted

Initial submission to the registry

July 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

10.2 years

First QC Date

July 22, 2016

Last Update Submit

October 5, 2022

Conditions

Carotid Artery Disease

Outcome Measures

Primary Outcomes (1)

  • One-year ipsilateral stroke or death

    Any death or stroke in the territory of the treated carotid artery within one year of the carotid artery treatment

    1 year

Secondary Outcomes (2)

  • 30-day Stroke or death

    30 days

  • 30-day Stroke, death or myocardial infarction

    30 days

Study Arms (2)

TCAR treatment

All patients, both high risk and standard 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

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

Interventions

Transcarotid artery revascularizationPROCEDURE

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

TCAR treatment
Carotid endarterectomyPROCEDURE

Removal of carotid atherosclerotic plaque (endarterectomy) via a surgical incision in the neck

CEA treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All patients undergoing TCAR or CEA both standard surgical risk and high surgical risk as defined by the CMS criteria published in the National Coverage Determination for Percutaneous Transluminal Angioplasty (20.7).

You may not qualify if:

  • Patients who have received a previous stent in the target artery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Society for Vascular Surgery Patient Safety Organization

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23406712BACKGROUND

  • 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.

    PMID: 26506270BACKGROUND

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marc L Schermerhorn, MD

    Society for Vascular Surgery Patient Safety Organization

    STUDY CHAIR

Central Study Contacts

James Wadzinski

CONTACT

312-334-2311jwadzinski@svspso.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 1, 2016

Study Start

November 1, 2016

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

October 7, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)