Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: Angiographic guided PCIProcedure: Augmented-Reality CTA guided PCI
- Registration Number
- NCT03531424
- Lead Sponsor
- Paul Knaapen
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angiographic guided PCI Angiographic guided PCI Angiographic guided PCI is coronary revascularization based on stand-alone angiography. CTA guided PCI Augmented-Reality CTA guided PCI CTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography.
- Primary Outcome Measures
Name Time Method Stent length 1 day Length of the stented segment
Predicted stent diameter 1 day Predicted final stent diameter according to a compliance chart
- Secondary Outcome Measures
Name Time Method Post-procedural volume of the reference segments 1 day Post-procedural volume of the reference segments by 3D QCA
Nominal stent diameter 1 day Nominal diameter of the implanted stent
Number of stents 1 day Total number of stents
Predilation 1 day Balloon predilation for lesion modification
Maximal balloon pressure 1 day Maximal balloon pressure applied during PCI
Maximal balloon diameter 1 day Maximal balloon diameter applied during PCI
Post-procedural residual area stenosis 1 day Post-procedural residual area stenosis by 3D QCA
Post-procedural minimum lumen diameter 1 day Post-procedural minimum lumen diameter by 3D QCA
Postdilation 1 day Balloon postdilation for stent expansion
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
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
Trial Locations
- Locations (1)
VU University Medical Center Amsterdam
🇳🇱Amsterdam, De Boelelaan 1117, Netherlands