IVUS-Guided Treatment for Percutaneous Vascular Interventions

Last updated: August 27, 2024
Sponsor: Philips Clinical & Medical Affairs Global
Overall Status: Suspended

Phase

N/A

Condition

Deep Vein Thrombosis

Treatment

IVUS Guided

Clinical Study ID

NCT06239493
200421
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The Patient is ≥18 years of age.

  2. Patient is scheduled to undergo percutaneous vascular intervention - peripheralvascular or coronary PCI procedure.

Exclusion

Exclusion Criteria:

  1. Patients not meeting the instructions for use (IFU) of the respective IVUScatheters.

  2. Patients with lesions or vessel segments deemed unsafe for multiple IVUS pullbacks.

  3. Patients who are pregnant.

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: IVUS Guided
Phase:
Study Start date:
September 14, 2023
Estimated Completion Date:
February 29, 2028

Study 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.

Connect with a study center

  • Southwest Cardiovascular Associates

    Mesa, Arizona 85208
    United States

    Site Not Available

  • Pulse Cardiovascular

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Center for Advanced Cardiac and Vascular Interventions

    Tarzana, California 91356
    United States

    Site Not Available

  • Pacific Cardiovascular and Vein Institute

    Ventura, California 93003
    United States

    Site Not Available

  • Community Healthcare System

    Munster, Indiana 46321
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.