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SVS VQI TransCarotid Revascularization Surveillance Project (VQI-TCAR)

This study is currently recruiting participants.
Verified July 2016 by Society for Vascular Surgery Patient Safety Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT02850588
First Posted: August 1, 2016
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Society for Vascular Surgery Patient Safety Organization
  Purpose
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 Intervention
Carotid Artery Disease Procedure: Transcarotid artery revascularization Procedure: Carotid endarterectomy

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Society for Vascular Surgery Patient Safety Organization:

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


Estimated Enrollment: 5000
Study Start Date: November 2016
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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

Publications:
Responsible Party: Society for Vascular Surgery Patient Safety Organization
ClinicalTrials.gov Identifier: NCT02850588     History of Changes
Other Study ID Numbers: VQI TCAR
First Submitted: July 22, 2016
First Posted: August 1, 2016
Last Update Posted: February 8, 2017
Last Verified: July 2016
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


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