Long-term Observational Extension of CREST-2

Overview

Información sobre este estudio

The purpose of this study is a long-term observational extension of the CREST-2 trial (C2LOE) to describe the comparative treatment effectiveness over a longer period of expected benefit from revascularization than can be accomplished in the parent trial alone. CREST-2 is a multicenter randomized trial of intensive medical management (IMM) with or without revascularization in patients with asymptomatic high-grade carotid stenosis (ClinicalTrials.gov Identifier: NCT02089217).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Eligibility for the parent CREST-2 trial included male and female individuals who are ≥ 35 years old and who have high-grade asymptomatic stenosis involving the cervical internal carotid artery.
  • A patient is considered asymptomatic in the absence of ipsilateral symptoms < 180 days prior to randomization.
  • Carotid stenosis is defined as high-grade if catheter angiography documents ≥ 70% stenosis per criteria used in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) or duplex ultrasonography (DU) documents peak systolic velocity (PSV) of ≥ 230 cm/s in combination with at least one of the following four criteria: end diastolic velocity of ≥ 100 cm/s, internal carotid artery-to-common carotid artery PSV ratio ≥ 4.0, computed tomography angiogram (CTA) showing ≥ 70% stenosis, or a magnetic resonance angiogram (MRA) showing ≥ 70% stenosis.
  • All currently active patients in the CREST-2 trial will be eligible for C2LOE. 
  • Most CREST-2 participants are Anglophone; however, there are also a small number of native French speakers (largely in Quebec, Canada) and native Spanish speakers (largely in Florida, Texas, and California sites, as well as the Barcelona, Spain center).
  • The Survey Research Unit (SRU) conducting the interviews can perform assessments in both French and Spanish, allowing inclusion of these patients in the long-term follow-up.

Exclusion Criteria:

  • Inability to secure written informed consent to be followed in this protocol.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

James Meschia, M.D.

Cerrado; inscripción por invitación

¿Qué es esto? (?)
"Close"
El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

James Meschia M.D.

(904) 953-6012

flacrest2@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20542169

Mayo Clinic Footer