IVUS-Guided Treatment for Percutaneous Vascular Interventions

Overview

The main objective of the study is to survey and improve the IVUS image quality and X-ray system interoperability by collecting Procedural Data (e.g. raw, pre- processed ultrasound and X-ray data, endpoints such as fluoroscopy time, contrast load and radiation dose, workflow details) during routine intravascular procedures to assure adherence to the high standards of quality during care delivery and promote procedural standardization.

This is a prospective, multicenter, single-arm study to collect procedural data (e.g., raw, pre-processed IVUS, X-ray, and other procedural data) for image quality, workflow and interoperability assessments. Example of additional procedural endpoint data (e.g., time for fluoroscopy and IVUS, contrast load and radiation dose, workflow details, etc.) will be collected. The study will be conducted in a phased approach. Since the collection of IVUS raw data with a second non-diagnostic pullback affects procedure time, the two aspects of this study - collection of raw IVUS data and procedural data, will be separated until IVUS raw data can be collected directly from the IVUS system with no additional procedural time.

Conditions

Interventions

Eligibility

Locations (5)

Outcomes