NCT07455747Recruiting
Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System
Boston Scientific Corporation
Start Date
8/19/2026
Completion Date
4/1/2030
Summary
The ENTRUST registry's objective is to collect real-world data (RWD) and health economic data on the ENROUTE™ Transcarotid Neuroprotection System (ENROUTE™ Transcarotid NPS), including populations in which outcomes of Transcarotid Artery Revascularization (TCAR) in patients with extracranial carotid artery disease are inadequately reported.
Detailed Description
A global prospective, single-arm, non-randomized, open-label, observational/non-interventional, multi-center registry to collect Real-World Data for TCAR procedure, including health economic data.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease
Conditions
Extracranial Carotid Artery DiseaseTCARTranscarotid Artery Revascularization
Locations
St. Luke's Episcopal-Presbyterian Hospital
St Louis, Missouri 63141
United States