Coronary Artery DiseaseAR-PCINCT03531424
Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study
A study testing Angiographic guided PCI and Augmented-Reality CTA guided PCI in people with Coronary Artery Disease, run by Paul Knaapen at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare revascularization strategy and its immediate results after augmented-reality computed tomography angiography (CTA) guided vs. standard angiography guided percutaneous coronary intervention (PCI) in native coronary lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Angiographic guided PCI and Augmented-Reality CTA guided PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Apr 2018to Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- patients with documented obstructive CAD defined as the presence of at least 1 stenosis ≥70% in a native coronary artery in whom PCI is considered based on clinical grounds
Who cannot join
- refusal or inability to provide written informed consent
- subjects in whom the quality of coronary CTA is insufficient
- bifurcation lesions, by which strategies other than a single cross-over stent technique are anticipated
- left main coronary artery stenosis
- chronic total occlusion
- in-stent restenosis
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- chronic renal failure (estimated glomerular filtration rate <30 ml/min)
- known allergy to contrast
- untreated hyperthyroidism
- pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
VU University Medical Center Amsterdam
Amsterdam, De Boelelaan 1117, 1081 HV
Maksymilian P. Opolski, MD, PhD, +48501444303, m.opolski@vumc.nl
Maksymilian P. Opolski, MD, PhD
About this study
Official title: On-Site Augmented-Reality Computed Tomography Plus Angiography Versus Angiography Alone for Guiding Percutaneous Coronary Intervention in Native Coronary Lesions - Randomized Study
The purpose of this study is to compare revascularization strategy and its immediate results after augmented-reality computed tomography angiography (CTA) guided vs. standard angiography guided percutaneous coronary intervention (PCI) in native coronary lesions.
Read the detailed description
While stand-alone angiography is the first-line imaging modality for guidance of PCI, it has some inherent limitations which may result in suboptimal stent placement related to residual reference segment disease and stent underexpansion. Coronary CTA, on the other hand, can provide reliable measurements of the vessel size and lesion length as well as the visualization of the morphological features of coronary plaque, and has been suggested as potentially valuable for changing PCI technique. The AR-PCI trial has been designed as a single-center, investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective clinical trial. It is hypothesized that the review of CTA datasets using augmented-reality glass in the catheterization laboratory could influence PCI treatment strategy and its immediate results by more adequate lesion coverage with less residual disease and better stent expansion as compared to traditional angiography-guided PCI alone.
- Conditions
- Coronary Artery Disease
- Being tested
- Angiographic guided PCI, Augmented-Reality CTA guided PCI
- Keywords
- Coronary Stenosis, Percutaneous Coronary Intervention, Stents, Computed Tomography Angiography, Augmented Reality
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiographic guided PCIProcedure or surgery
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
Augmented-Reality CTA guided PCIProcedure or surgery
Augmented-Reality CTA guided PCI is coronary revascularization based on systematic use of CTA datasets displayed in augmented-reality glass plus coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| Angiographic guided PCI | Active comparator | Angiographic guided PCI is coronary revascularization based on stand-alone angiography. Receives: Procedure: Angiographic guided PCI |
| CTA guided PCI | Experimental | CTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography. Receives: Procedure: Augmented-Reality CTA guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent length
Length of the stented segment
Measured: 1 day
Predicted stent diameter
Predicted final stent diameter according to a compliance chart
Measured: 1 day
Secondary outcomes (15)
Nominal stent diameter
Nominal diameter of the implanted stent
Measured: 1 day
Number of stents
Total number of stents
Measured: 1 day
Predilation
Balloon predilation for lesion modification
Measured: 1 day
Postdilation
Balloon postdilation for stent expansion
Measured: 1 day
Maximal balloon pressure
Maximal balloon pressure applied during PCI
Measured: 1 day
Maximal balloon diameter
Maximal balloon diameter applied during PCI
Measured: 1 day
Stent-edge dissection
Stent-edge dissection by coronary angiography
Measured: 1 day
Post-procedural residual diameter stenosis
Post-procedural residual diameter stenosis by 3D QCA
Measured: 1 day
Post-procedural residual area stenosis
Post-procedural residual area stenosis by 3D QCA
Measured: 1 day
Post-procedural minimum lumen diameter
Post-procedural minimum lumen diameter by 3D QCA
Measured: 1 day
Post-procedural minimum lumen area
Post-procedural minimum lumen area by 3D QCA
Measured: 1 day
Post-procedural lumen diameters at the reference segments
Post-procedural lumen diameters at the reference segments by 3D QCA
Measured: 1 day
Post-procedural lumen areas at the reference segments
Post-procedural lumen areas at the reference segments by 3D QCA
Measured: 1 day
Post-procedural volume of the stented segment
Post-procedural volume of the stented segment by 3D QCA
Measured: 1 day
Post-procedural volume of the reference segments
Post-procedural volume of the reference segments by 3D QCA
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start25 Apr 2018
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Knaapen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Knaapen, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531424
- Sponsor's protocol ID
- NL63928.029.17
- Acronym
- AR-PCI
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-Site Augmented-Reality Computed Tomography Plus Angiography Versus Angiography Alone for Guiding Percutaneous Coronary Intervention in Native Coronary Lesions - Randomized Study
- ClinicalTrials.gov ID
- NCT03531424
- Acronym / sponsor ID
- AR-PCI / NL63928.029.17
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Stenosis, Percutaneous Coronary Intervention, Stents, Computed Tomography Angiography, Augmented Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Paul KnaapenUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 May 2018 (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 purpose of this study is to compare revascularization strategy and its immediate results after augmented-reality computed tomography angiography (CTA) guided vs. standard angiography guided percutaneous coronary intervention (PCI) in native coronary lesions.
Detailed description
While stand-alone angiography is the first-line imaging modality for guidance of PCI, it has some inherent limitations which may result in suboptimal stent placement related to residual reference segment disease and stent underexpansion. Coronary CTA, on the other hand, can provide reliable measurements of the vessel size and lesion length as well as the visualization of the morphological features of coronary plaque, and has been suggested as potentially valuable for changing PCI technique. The AR-PCI trial has been designed as a single-center, investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective clinical trial. It is hypothesized that the review of CTA datasets using augmented-reality glass in the catheterization laboratory could influence PCI treatment strategy and its immediate results by more adequate lesion coverage with less residual disease and better stent expansion as compared to traditional angiography-guided PCI alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiographic guided PCI | Active comparator | Procedure: Angiographic guided PCIAngiographic guided PCI is coronary revascularization based on stand-alone angiography. |
| CTA guided PCI | Experimental | Procedure: Augmented-Reality CTA guided PCICTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with documented obstructive CAD defined as the presence of at least 1 stenosis ≥70% in a native coronary artery in whom PCI is considered based on clinical grounds
Key exclusion criteria (10 listed)
- refusal or inability to provide written informed consent
- subjects in whom the quality of coronary CTA is insufficient
- bifurcation lesions, by which strategies other than a single cross-over stent technique are anticipated
- left main coronary artery stenosis
- chronic total occlusion
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 |
|---|---|---|
| Angiographic guided PCIAngiographic guided PCI is coronary revascularization based on stand-alone angiography. | Procedure or surgery | Angiographic guided PCI |
| Augmented-Reality CTA guided PCIAugmented-Reality CTA guided PCI is coronary revascularization based on systematic use of CTA datasets displayed in augmented-reality glass plus coronary angiography. | Procedure or surgery | CTA guided PCI |
Primary outcome
Stent length
Time frame: 1 day
Length of the stented segment
Predicted stent diameter
Time frame: 1 day
Predicted final stent diameter according to a compliance chart
15 secondary outcomes
Nominal stent diameter
Time frame: 1 day
Number of stents
Time frame: 1 day
Predilation
Time frame: 1 day
Postdilation
Time frame: 1 day
Maximal balloon pressure
Time frame: 1 day
Maximal balloon diameter
Time frame: 1 day
Stent-edge dissection
Time frame: 1 day
Post-procedural residual diameter stenosis
Time frame: 1 day
Post-procedural residual area stenosis
Time frame: 1 day
Post-procedural minimum lumen diameter
Time frame: 1 day
Post-procedural minimum lumen area
Time frame: 1 day
Post-procedural lumen diameters at the reference segments
Time frame: 1 day
Post-procedural lumen areas at the reference segments
Time frame: 1 day
Post-procedural volume of the stented segment
Time frame: 1 day
Post-procedural volume of the reference segments
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiographic guided PCI and Augmented-Reality CTA guided PCI in people with Coronary Artery Disease, run by Paul Knaapen at 1 site in Netherlands.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 May 2018. 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 Netherlands. 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?
Contact Maksymilian P. Opolski, MD, PhD (+48501444303, m.opolski@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent length (time frame: 1 day). The study lists 2 primary outcomes in all. 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 22 May 2018.