Extracranial Carotid Artery Disease, TCAR, Transcarotid Artery Revascularization
Conditions
Keywords
Carotid Artery Disease
Brief 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 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.
Interventions
DEVICEUse of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease
ENROUTE™ Transcarotid NPS AND ENROUTE™ Transcarotid Stent System. Additionally, ENROUTE™ Transcarotid NPS AND any commercially available Boston Scientific stent marketed for treatment of carotid artery disease may be added upon commercial availability.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | within 30 days (death, stroke, or MI); within 31-365 days (ipsilateral stroke) | Major Adverse Events (MAEs) defined as a composite outcome including any death, stroke, or myocardial infarction (MI) within 30 days of the index procedure and ipsilateral stroke within 31 days to 365 days of the index procedure. No pre-specified endpoints or formal tests of hypotheses are proposed. Analyses will be performed for exploratory purposes. |
Contacts
CONTACTErin Hammer
PRINCIPAL_INVESTIGATORAngela H Martin, MD
Evansville Surgical Associates
Outcome results
None listed