An interventional study of Angiographic guided PCI and Augmented-Reality CTA guided PCI in Coronary Artery Disease, sponsored by Paul Knaapen. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-22.
Sponsored by Paul Knaapen · Not applicable, Interventional, and Treatment
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 60 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →This is the only study on the registry with Paul Knaapen as lead sponsor.
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Exclusion Criteria:
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
Procedure: Angiographic guided PCI
CTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography.
Procedure: Augmented-Reality CTA guided PCI
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
Augmented-Reality CTA guided PCI is coronary revascularization based on systematic use of CTA datasets displayed in augmented-reality glass plus coronary angiography.
Stent length
Length of the stented segment
Time frame: 1 day
Predicted stent diameter
Predicted final stent diameter according to a compliance chart
Time frame: 1 day
Nominal stent diameter
Nominal diameter of the implanted stent
Time frame: 1 day
Number of stents
Total number of stents
Time frame: 1 day
Predilation
Balloon predilation for lesion modification
Time frame: 1 day
Postdilation
Balloon postdilation for stent expansion
Time frame: 1 day
Maximal balloon pressure
Maximal balloon pressure applied during PCI
Time frame: 1 day
Maximal balloon diameter
Maximal balloon diameter applied during PCI
Time frame: 1 day
Stent-edge dissection
Stent-edge dissection by coronary angiography
Time frame: 1 day
Post-procedural residual diameter stenosis
Post-procedural residual diameter stenosis by 3D QCA
Time frame: 1 day
Post-procedural residual area stenosis
Post-procedural residual area stenosis by 3D QCA
Time frame: 1 day
Post-procedural minimum lumen diameter
Post-procedural minimum lumen diameter by 3D QCA
Time frame: 1 day
Post-procedural minimum lumen area
Post-procedural minimum lumen area by 3D QCA
Time frame: 1 day
Post-procedural lumen diameters at the reference segments
Post-procedural lumen diameters at the reference segments by 3D QCA
Time frame: 1 day
Post-procedural lumen areas at the reference segments
Post-procedural lumen areas at the reference segments by 3D QCA
Time frame: 1 day
Post-procedural volume of the stented segment
Post-procedural volume of the stented segment by 3D QCA
Time frame: 1 day
Post-procedural volume of the reference segments
Post-procedural volume of the reference segments by 3D QCA
Time frame: 1 day
Plan to share: No
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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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