Clinical trial NCT06239493: IVUS-Guided Treatment for Percutaneous Vascular Interventions
Official title: IVUS-Guided Treatment for Percutaneous Vascular Interventions
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: CAD
PAD
DVT
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers aged 18 and older scheduled to undergo a percutaneous vascular intervention.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improve
timeFrame: Procedure (one visit)
Secondary outcomes:
measure: Procedural IVUS TIME
timeFrame: Procedure (one visit)
measure: PROCEDURAL RADIATION DOSE
timeFrame: Procedure (one visit)
measure: PROCEDURAL AMOUNT OF CONTRAST USED
timeFrame: Procedure (one visit)
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Southwest Cardiovascular Associates
state: Arizona
city: Scottsdale
country: United States
facility: Pulse Cardiovascular
state: Arizona
city: Tarzana
country: United States
facility: Center for Advanced Cardiac and Vascular Interventions
state: California
city: Ventura
country: United States
facility: Pacific Cardiovascular and Vein Institute
state: California
city: Munster
country: United States
facility: Community Healthcare System
state: Indiana
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Eric Secemsky, MD
role: STUDY_CHAIR
References: