Long-Term Observational Extension of Participants in CREST-2Trial (C2LOE)

Overview

About this study

The primary specific aim of the study is to compare the post-procedure treatment differences in stroke risk between those randomized to revascularization and intensive medical management (IMM) and those randomized to IMM alone. This difference will be assessed using proportional hazards analysis, with the primary analysis restricted to those who are stroke-free at the end of the 44-day periprocedural period and with the primary analysis being performed on the intention-to-treat population.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Currently active or graduated participants in the CREST-2 randomized trial at a site located in the United States.

- Able to provide written informed consent by self.

- Fluent in English.

Exclusion Criteria:

- Unable to provide written informed consent.

- Inability to follow study procedures.

Eligibility last updated 2/20/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Giuseppe Lanzino, M.D.

Open for enrollment

Contact information:

Rebecca Ranfranz

(507) 293-7354

Ranfranz.Rebecca@mayo.edu

More information

Publications

Publications are currently not available