IVUS-Guided Treatment for Percutaneous Vascular Interventions (IGT-PVI)
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About
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.
Full description
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.
Enrollment
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Inclusion criteria
- The Patient is ≥18 years of age.
- Patient is scheduled to undergo percutaneous vascular intervention - peripheral vascular or coronary PCI procedure.
Exclusion criteria
- Patients not meeting the instructions for use (IFU) of the respective IVUS catheters.
- Patients with lesions or vessel segments deemed unsafe for multiple IVUS pullbacks.
- Patients who are pregnant.
Trial design
5,000 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Carrie Hill; Nikhil Rajguru
Data sourced from clinicaltrials.gov
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