IVUS-Guided Treatment for Percutaneous Vascular Interventions

NCT06239493 — Suspended, 5000 participants, Philips Clinical & Medical Affairs Global

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Registry	NCT06239493, acronym IGT-PVI
Status	Suspended - Business Decision
Study type	Observational
Enrollment	5000 (Estimated)
Sponsor	Philips Clinical & Medical Affairs Global (Industry)
Conditions	CAD, PAD, DVT
Interventions	IVUS Guided (Diagnostic test)
Dates	start 2023-09-14, primary completion 2028-02-01 (estimated), completion 2028-02-01 (estimated), first posted 2024-02-02, last updated 2025-05-31
Locations	5 sites in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
IVUS GUIDED		Diagnostic Test: IVUS Guided	Those undergoing an already planned IVUS guided treatment for percutaneous vascular interventions

IVUS Guided (Diagnostic test): Those already undergoing an IVUS guided percutaneous vascular intervention

+Outcome measures

Primary outcomes

Improve [Procedure (one visit)]: Analyze IVUS images for improvement using manual and automated visualization

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (5)

Facility	City	Country
Southwest Cardiovascular Associates	Mesa, Arizona	United States
Pulse Cardiovascular	Scottsdale, Arizona	United States
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

+Investigators

Eric Secemsky, MD, Study chair, Beth Israel Deaconess Medical Center