CAD, DVT, PAD
Conditions
Brief summary
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTIVUS Guided
Those already undergoing an IVUS guided percutaneous vascular intervention
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The Patient is ≥18 years of age. 2. Patient is scheduled to undergo percutaneous vascular intervention - peripheral vascular or coronary PCI procedure.
Exclusion criteria
1. Patients not meeting the instructions for use (IFU) of the respective IVUS catheters. 2. Patients with lesions or vessel segments deemed unsafe for multiple IVUS pullbacks. 3. Patients who are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improve | Procedure (one visit) | Analyze IVUS images for improvement using manual and automated visualization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural IVUS TIME | Procedure (one visit) | Procedural time will be recorded. IVUS time of insert and time of removal |
| PROCEDURAL RADIATION DOSE | Procedure (one visit) | Radiation dose used during procedure will be recorded |
| PROCEDURAL AMOUNT OF CONTRAST USED | Procedure (one visit) | Amount of contrast used during procedure will be recorded |
Countries
United States
Outcome results
None listed