Coronary Artery Disease
Conditions
Keywords
Coronary Stenosis, Percutaneous Coronary Intervention, Stents, Computed Tomography Angiography, Augmented Reality
Brief 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.
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.
Interventions
PROCEDUREAngiographic guided PCI
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
PROCEDUREAugmented-Reality CTA guided PCI
Augmented-Reality CTA guided PCI is coronary revascularization based on systematic use of CTA datasets displayed in augmented-reality glass plus coronary angiography.
Sponsors
Paul Knaapen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * chronic renal failure (estimated glomerular filtration rate \<30 ml/min) * known allergy to contrast * untreated hyperthyroidism * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent length | 1 day | Length of the stented segment |
| Predicted stent diameter | 1 day | Predicted final stent diameter according to a compliance chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predilation | 1 day | Balloon predilation for lesion modification |
| Postdilation | 1 day | Balloon postdilation for stent expansion |
| Maximal balloon pressure | 1 day | Maximal balloon pressure applied during PCI |
| Maximal balloon diameter | 1 day | Maximal balloon diameter applied during PCI |
| Stent-edge dissection | 1 day | Stent-edge dissection by coronary angiography |
| Post-procedural residual diameter stenosis | 1 day | Post-procedural residual diameter stenosis by 3D QCA |
| Nominal stent diameter | 1 day | Nominal diameter of the implanted stent |
| Post-procedural minimum lumen diameter | 1 day | Post-procedural minimum lumen diameter by 3D QCA |
| Post-procedural minimum lumen area | 1 day | Post-procedural minimum lumen area by 3D QCA |
| Post-procedural lumen diameters at the reference segments | 1 day | Post-procedural lumen diameters at the reference segments by 3D QCA |
| Post-procedural lumen areas at the reference segments | 1 day | Post-procedural lumen areas at the reference segments by 3D QCA |
| Post-procedural volume of the stented segment | 1 day | Post-procedural volume of the stented segment by 3D QCA |
| Post-procedural volume of the reference segments | 1 day | Post-procedural volume of the reference segments by 3D QCA |
| Post-procedural residual area stenosis | 1 day | Post-procedural residual area stenosis by 3D QCA |
| Number of stents | 1 day | Total number of stents |
Countries
Netherlands
Contacts
Primary ContactMaksymilian P. Opolski, MD, PhD
Outcome results
None listed