IVUS-Guided Treatment for Percutaneous Vascular Interventions

CAD Clinical Trial

— IGT-PVI  

Official title:

IVUS-Guided Treatment for Percutaneous Vascular Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239493
• Other study ID #: 200421
• Status: Recruiting
• Start date: September 14, 2023
• Est. completion date: February 2028

Study information

• Verified date: January 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: Carrie Hill
• Phone: 612-398-6663
• Email: carrie.hill[@]philips.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CAD
• DVT
• PAD

Intervention

Diagnostic Test:
• IVUS Guided
Those already undergoing an IVUS guided percutaneous vascular intervention

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve	Analyze IVUS images for improvement using manual and automated visualization	Procedure (one visit)
Secondary	Procedural IVUS TIME	Procedural time will be recorded. IVUS time of insert and time of removal	Procedure (one visit)
Secondary	PROCEDURAL RADIATION DOSE	Radiation dose used during procedure will be recorded	Procedure (one visit)
Secondary	PROCEDURAL AMOUNT OF CONTRAST USED	Amount of contrast used during procedure will be recorded	Procedure (one visit)