Transcarotid Neuroprotection System with TCAR for Carotid Artery Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, prospective registry collects real-world data on TCAR procedures using the ENROUTE Neuroprotection System, across multiple centers, without randomization. It aims to describe outcomes and health economics in adults with extracranial carotid artery disease where TCAR results are not well reported. Data will come from patients treated with ENROUTE alongside commercially available carotid stents, with follow-up aligned to registry protocols. The study is non-interventional and observational, focusing on routine clinical practice outside of a controlled trial setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient is ≥ 18 years of age\*
* Written informed consent (patient data-release form)
* Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease and specified in the Registry Enrollment Guide(s).

  * Refer to the Registry Enrollment Guide for details on enrollment restrictions based on patient age

Exclusion Criteria:

* Life expectancy of \< 1 year or patient is unlikely to derive net clinical benefit from carotid revascularization.
* 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.

Where it's running

• St. Luke's Episcopal-Presbyterian Hospital
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Angela H Martin, MD — Evansville Surgical Associates
• Study coordinator: Erin Hammer
• Email: Erin.Hammer@bsci.com
• Phone: 952-356-2730

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.