IVUS-Guided Treatment for Percutaneous Vascular Interventions

Suspended

• Conditions: CAD; DVT; PAD
• Interventions: Diagnostic Test: IVUS Guided

• Registration Number: NCT06239493
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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.

Study Timeline

• Study Start: 2023-09-14
• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29
• Primary Completion: 2028-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IVUS GUIDED	IVUS Guided	Those undergoing an already planned IVUS guided treatment for percutaneous vascular interventions

Primary Outcome Measures

Name	Time	Method
Improve	Procedure (one visit)	Analyze IVUS images for improvement using manual and automated visualization

Secondary Outcome Measures

Name	Time	Method
Procedural IVUS TIME	Procedure (one visit)	Procedural time will be recorded. IVUS time of insert and time of removal
PROCEDURAL AMOUNT OF CONTRAST USED	Procedure (one visit)	Amount of contrast used during procedure will be recorded
PROCEDURAL RADIATION DOSE	Procedure (one visit)	Radiation dose used during procedure will be recorded

Trial Locations

Locations (5)

Center for Advanced Cardiac and Vascular Interventions; 🇺🇸 Tarzana, California, United States

Pacific Cardiovascular and Vein Institute; 🇺🇸 Ventura, California, United States

Community Healthcare System; 🇺🇸 Munster, Indiana, United States

Southwest Cardiovascular Associates; 🇺🇸 Mesa, Arizona, United States

Pulse Cardiovascular; 🇺🇸 Scottsdale, Arizona, United States