Coronary StenosisNCT02927990

Contrast Volume Reduction During PCI With the Use of a New Assisting Software Package

An observational study of Coronary Stenosis and Coronary Occlusion, run by Philips Clinical & Medical Affairs Global at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The new software package is intended to assist the physician in imaging the coronaries during percutaneous coronary interventions. This study investigates the amount of contrast used during percutaneous coronary interventions with the aid of the new software package. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Stenosis, Coronary Occlusion
What is being tested?: Percutaneous Coronary Intervention
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 15 Dec 2017to 30 Jun 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Patients with age 18 or older, of both genders and all races. Patients undergoing a percutaneous coronary intervention. Patients are considered to be enrolled in the study after they have signed the informed consent form.

Who may be able to join

Subject undergoing a percutaneous coronary intervention.
Subject 18 years of age or older, or of legal age to give informed consent per state or national law.

Who cannot join

Subject undergoing an emergency treatment
Primary angioplasty for acute ST segment elevation myocardial infarction.
Subject with contrast allergies
Subject with severe kidney disease (e-GFR < 40 by Modification of Diet in Renal Disease (MDRD)/Cockcroft Gault clearance formula and/or upon decision by investigator)
Subject participates in a potentially confounding drug or device trial during the course of the study.
Prisoners, people who cannot legally give consent, pregnant women and breastfeeding women.

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Medical Center/NYPH
New York, New York, 10032

Other trials in United States

About this study

Official title: Contrast Volume Reduction During Percutaneous Coronary Interventions With the Use of a New Assisting Software Package

The new software package is intended to assist the physician in imaging the coronaries during percutaneous coronary interventions.

This study investigates the amount of contrast used during percutaneous coronary interventions with the aid of the new software package.

The results of the study will be compared with control group data (before the new software package was installed or after it was removed) to define a possible contrast reduction.

Conditions: Coronary Stenosis, Coronary Occlusion
Being tested: Percutaneous Coronary Intervention
Medical subject headings: Coronary Stenosis, Coronary Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous Coronary InterventionOther
Percutaneous Coronary Intervention according to standard of care

Study groups in NCT02927990
Study group	Role	What they receive
Study group		Percutaneous coronary interventions with additional imaging provided by the new software package Receives: Other: Percutaneous Coronary Intervention
Control group		Percutaneous coronary interventions without the new software package Receives: Other: Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Amount [mL] of Contrast Used for Completion of the Coronary Intervention
Phase 2 not initiated Only phase 1 data was collected
Measured: Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.

Secondary outcomes (4)

Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention
No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
Measured: DAP [mGycm^2] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Cumulative Air-Kerma (AK) of Percutaneous Coronary Intervention
No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
Measured: AK [mGy] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Total Fluoroscopy Time of Percutaneous Coronary Intervention
No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
Measured: Fluoroscopy time [minutes] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Procedure Efficiency
The endpoint is procedural timing:
- time from start of procedure (wire introduced into the coronary)
- end of procedure (start of vascular closure)
- time until wire placed in distal coronary bed for purpose of intervention
- time of first stent placement
Measured: Patients will be followed from start of interventional procedure (vascular access obtained) until end of the procedure (vascular closure), ranging between 30 minutes and a few hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 201730 Jun 2019

First posted7 Oct 2016 (estimated)
Study start15 Dec 2017
Primary completion30 Jun 2019
Study completion30 Jun 2019

Why it stopped: Insights and learnings were used to initiate an improved multicenter study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary StenosisStudies 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: Cohort
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02927990
Sponsor's protocol ID: XCY607-130198
Status last verified: Dec 2024
First submitted: 23 Sep 2016
Last updated: 6 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contrast Volume Reduction During Percutaneous Coronary Interventions With the Use of a New Assisting Software Package
ClinicalTrials.gov ID: NCT02927990
Acronym / sponsor ID: XCY607-130198
Conditions: Coronary Stenosis, Coronary Occlusion
Study type: Observational
Recruitment status: TerminatedReason stopped: Insights and learnings were used to initiate an improved multicenter study.
Enrolment: 80 participants (actual)
Lead sponsor: Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
Study start: 15 Dec 2017 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 7 Oct 2016 (estimated)
Results: Posted 6 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The new software package is intended to assist the physician in imaging the coronaries during percutaneous coronary interventions.

This study investigates the amount of contrast used during percutaneous coronary interventions with the aid of the new software package.

The results of the study will be compared with control group data (before the new software package was installed or after it was removed) to define a possible contrast reduction.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Study group	–	Other: Percutaneous Coronary InterventionPercutaneous coronary interventions with additional imaging provided by the new software package
Control group	–	Other: Percutaneous Coronary InterventionPercutaneous coronary interventions without the new software package

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with age 18 or older, of both genders and all races. Patients undergoing a percutaneous coronary intervention. Patients are considered to be enrolled in the study after they have signed the informed consent form.

Key inclusion criteria (2 listed)

Subject undergoing a percutaneous coronary intervention.
Subject 18 years of age or older, or of legal age to give informed consent per state or national law.

Key exclusion criteria (6 listed)

Subject undergoing an emergency treatment
Primary angioplasty for acute ST segment elevation myocardial infarction.
Subject with contrast allergies
Subject with severe kidney disease (e-GFR < 40 by Modification of Diet in Renal Disease (MDRD)/Cockcroft Gault clearance formula and/or upon decision by investigator)
Subject participates in a potentially confounding drug or device trial during the course of the study.

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
Percutaneous Coronary InterventionPercutaneous Coronary Intervention according to standard of care	Other	Control group, Study group

Primary outcome

Amount [mL] of Contrast Used for Completion of the Coronary Intervention
Time frame: Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Phase 2 not initiated Only phase 1 data was collected

4 secondary outcomes

Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention
Time frame: DAP [mGycm^2] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Cumulative Air-Kerma (AK) of Percutaneous Coronary Intervention
Time frame: AK [mGy] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Total Fluoroscopy Time of Percutaneous Coronary Intervention
Time frame: Fluoroscopy time [minutes] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Procedure Efficiency
Time frame: Patients will be followed from start of interventional procedure (vascular access obtained) until end of the procedure (vascular closure), ranging between 30 minutes and a few hours.

Results and safety

Results posted to the registry on 6 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subject Undergoing PCI Phase 1	80	24

Primary outcome: Amount [mL] of Contrast Used for Completion of the Coronary Intervention

Time frame: Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.. Median (Standard Deviation). Unit: mL

Measure	PCI Phase 1 n = 23	PCI Phase 2 n = 0
Value	210 (108.77)	–

Population analysed: No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients were followed-up until discharge through study completion, which was 1 day on average.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PCI Phase 1	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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Not yet recruiting
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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.

Manish Parikh, MD principal investigator

Columbia University Medical Center/NYPH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Stenosis and Coronary Occlusion, run by Philips Clinical & Medical Affairs Global at 1 site 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 6 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: stopped early, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Amount [mL] of Contrast Used for Completion of the Coronary Intervention (time frame: Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02927990.

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 6 Dec 2024.