Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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On-Site Augmented-Reality Computed Tomography Plus Angiography Versus Angiography Alone for Guiding Percutaneous Coronary Intervention in Native Coronary Lesions - Randomized Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Angiographic guided PCI
* Procedure: Augmented-Reality CTA guided PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angiographic guided PCI<br>Angiographic guided PCI is coronary revascularization based on stand-alone angiography. | Procedure: Angiographic guided PCI<br>* Angiographic guided PCI is coronary revascularization based on stand-alone angiography.<br>|
| Experimental: CTA guided PCI<br>CTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography. | Procedure: Augmented-Reality CTA guided PCI<br>* Augmented-Reality CTA guided PCI is coronary revascularization based on systematic use of CTA datasets displayed in augmented-reality glass plus coronary angiography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent length | Length of the stented segment | 1 day | 
| Predicted stent diameter | Predicted final stent diameter according to a compliance chart | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nominal stent diameter | Nominal diameter of the implanted stent | 1 day | 
| Number of stents | Total number of stents | 1 day | 
| Predilation | Balloon predilation for lesion modification | 1 day | 
| Postdilation | Balloon postdilation for stent expansion | 1 day | 
| Maximal balloon pressure | Maximal balloon pressure applied during PCI | 1 day | 
| Maximal balloon diameter | Maximal balloon diameter applied during PCI | 1 day | 
| Stent-edge dissection | Stent-edge dissection by coronary angiography | 1 day | 
| Post-procedural residual diameter stenosis | Post-procedural residual diameter stenosis by 3D QCA | 1 day | 
| Post-procedural residual area stenosis | Post-procedural residual area stenosis by 3D QCA | 1 day | 
| Post-procedural minimum lumen diameter | Post-procedural minimum lumen diameter by 3D QCA | 1 day | 
| Post-procedural minimum lumen area | Post-procedural minimum lumen area by 3D QCA | 1 day | 
| Post-procedural lumen diameters at the reference segments | Post-procedural lumen diameters at the reference segments by 3D QCA | 1 day | 
| Post-procedural lumen areas at the reference segments | Post-procedural lumen areas at the reference segments by 3D QCA | 1 day | 
| Post-procedural volume of the stented segment | Post-procedural volume of the stented segment by 3D QCA | 1 day | 
| Post-procedural volume of the reference segments | Post-procedural volume of the reference segments by 3D QCA | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Stenosis, Percutaneous Coronary Intervention, Stents, Computed Tomography Angiography, Augmented Reality