CADIGT-PVINCT06239493
IVUS-Guided Treatment for Percutaneous Vascular Interventions
An observational study of CAD and PAD, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- IVUS Guided
- How many people
- 5,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Sep 2023to Feb 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All comers aged 18 and older scheduled to undergo a percutaneous vascular intervention.
Who may be able to join
- The Patient is ≥18 years of age.
- Patient is scheduled to undergo percutaneous vascular intervention - peripheral vascular or coronary PCI procedure.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Southwest Cardiovascular Associates
Mesa, Arizona, 85208
Community Healthcare System
Munster, Indiana, 46321
Pulse Cardiovascular
Scottsdale, Arizona, 85251
Center for Advanced Cardiac and Vascular Interventions
Tarzana, California, 91356
Pacific Cardiovascular and Vein Institute
Ventura, California, 93003
About this study
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.
Read the 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.
- Being tested
- IVUS Guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS GuidedDiagnostic test
Those already undergoing an IVUS guided percutaneous vascular intervention
| Study group | Role | What they receive |
|---|---|---|
| IVUS GUIDED | Those undergoing an already planned IVUS guided treatment for percutaneous vascular interventions Receives: Diagnostic Test: IVUS Guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve
Analyze IVUS images for improvement using manual and automated visualization
Measured: Procedure (one visit)
Secondary outcomes (3)
Procedural IVUS TIME
Procedural time will be recorded. IVUS time of insert and time of removal
Measured: Procedure (one visit)
PROCEDURAL RADIATION DOSE
Radiation dose used during procedure will be recorded
Measured: Procedure (one visit)
PROCEDURAL AMOUNT OF CONTRAST USED
Amount of contrast used during procedure will be recorded
Measured: Procedure (one visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start14 Sep 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CADStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Secemsky, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239493
- Sponsor's protocol ID
- 200421
- Acronym
- IGT-PVI
- Status last verified
- May 2025
- First submitted
- 18 Dec 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVUS-Guided Treatment for Percutaneous Vascular Interventions
- ClinicalTrials.gov ID
- NCT06239493
- Acronym / sponsor ID
- IGT-PVI / 200421
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Business Decision
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVUS GUIDED | – | Diagnostic Test: IVUS GuidedThose undergoing an already planned IVUS guided treatment for percutaneous vascular interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All comers aged 18 and older scheduled to undergo a percutaneous vascular intervention.
Key inclusion criteria (2 listed)
- The Patient is ≥18 years of age.
- Patient is scheduled to undergo percutaneous vascular intervention - peripheral vascular or coronary PCI procedure.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUS GuidedThose already undergoing an IVUS guided percutaneous vascular intervention | Diagnostic test | IVUS GUIDED |
Primary outcome
Improve
Time frame: Procedure (one visit)
Analyze IVUS images for improvement using manual and automated visualization
3 secondary outcomes
Procedural IVUS TIME
Time frame: Procedure (one visit)
PROCEDURAL RADIATION DOSE
Time frame: Procedure (one visit)
PROCEDURAL AMOUNT OF CONTRAST USED
Time frame: Procedure (one visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Secemsky, MD study chair
Beth Israel Deaconess Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CAD and PAD, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve (time frame: Procedure (one visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.