Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)

Launched by SHANGHAI BLUESAIL BOYUAN MEDICAL TECHNOLOGY CO., LTD. · Apr 13, 2025

Keywords

ClinConnect Summary

The CREATE Trial is a study looking at a new treatment for patients with narrowed carotid arteries caused by calcium build-up, a condition known as carotid artery stenosis. The goal of this trial is to see how safe and effective a special device called the intravascular lithotripsy system is when used before traditional surgery. This study will involve 204 participants who are already part of a larger clinical trial, and they will be monitored for up to six months after their treatment to see how well the procedure works and if there are any complications.

To be eligible for this trial, participants need to be between the ages of 65 and 74 and have already enrolled in the prior study. Everyone involved will receive thorough information about the trial and will need to give their consent before participating. The trial is led by Professor Huo Xiaochuan at Beijing Anzhen Hospital and is sponsored by Shanghai Lanfan Boyuan Medical Technology Co., Ltd. Participants can expect follow-up visits at three months and six months after their treatment to check on their recovery and the success of the procedure.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • All patients participating in this extended follow-up period are sourced from the registered clinical trial.
• Exclusion criteria:
• • none