IVUS-Guided Treatment for Percutaneous Vascular Interventions

NCT06239493 | Suspended

• 1 other identifier: 200421
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 5

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.

Conditions

CAD; PAD; DVT

Outcome Measures

Primary Outcomes (1)

• Improve

  Analyze IVUS images for improvement using manual and automated visualization

  Procedure (one visit)

Secondary Outcomes (3)

• Procedural IVUS TIME

  Procedure (one visit)

• PROCEDURAL RADIATION DOSE

  Procedure (one visit)

• PROCEDURAL AMOUNT OF CONTRAST USED

  Procedure (one visit)

Study Arms (1)

IVUS GUIDED

Those undergoing an already planned IVUS guided treatment for percutaneous vascular interventions

Diagnostic Test: IVUS Guided

Interventions

IVUS Guided DIAGNOSTIC_TEST

Those already undergoing an IVUS guided percutaneous vascular intervention

IVUS GUIDED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All comers aged 18 and older scheduled to undergo a percutaneous vascular intervention.

You may qualify if:

• The Patient is ≥18 years of age.
• Patient is scheduled to undergo percutaneous vascular intervention - peripheral vascular or coronary PCI procedure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (5)

Southwest Cardiovascular Associates

Mesa, Arizona, 85208, United States

Location

Pulse Cardiovascular

Scottsdale, Arizona, 85251, United States

Location

Center for Advanced Cardiac and Vascular Interventions

Tarzana, California, 91356, United States

Location

Pacific Cardiovascular and Vein Institute

Ventura, California, 93003, United States

Location

Community Healthcare System

Munster, Indiana, 46321, United States

Location

Study Officials

• Eric Secemsky, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: February 2, 2024
• Study Start: September 14, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (5)