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

Coronary Artery Disease Clinical Trial

— AR-PCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03531424
• Other study ID #: NL63928.029.17
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: VU University Medical Center
• Contact: Maksymilian P. Opolski, MD, PhD
• Phone: +48501444303
• Email: m.opolski[@]vumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Angiographic guided PCI
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
• Augmented-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.

Locations

Country	Name	City	State
Netherlands	VU University Medical Center Amsterdam	Amsterdam	De Boelelaan 1117

Sponsors (1)

Lead Sponsor	Collaborator
Paul Knaapen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent length	Length of the stented segment	1 day
Primary	Predicted stent diameter	Predicted final stent diameter according to a compliance chart	1 day
Secondary	Nominal stent diameter	Nominal diameter of the implanted stent	1 day
Secondary	Number of stents	Total number of stents	1 day
Secondary	Predilation	Balloon predilation for lesion modification	1 day
Secondary	Postdilation	Balloon postdilation for stent expansion	1 day
Secondary	Maximal balloon pressure	Maximal balloon pressure applied during PCI	1 day
Secondary	Maximal balloon diameter	Maximal balloon diameter applied during PCI	1 day
Secondary	Stent-edge dissection	Stent-edge dissection by coronary angiography	1 day
Secondary	Post-procedural residual diameter stenosis	Post-procedural residual diameter stenosis by 3D QCA	1 day
Secondary	Post-procedural residual area stenosis	Post-procedural residual area stenosis by 3D QCA	1 day
Secondary	Post-procedural minimum lumen diameter	Post-procedural minimum lumen diameter by 3D QCA	1 day
Secondary	Post-procedural minimum lumen area	Post-procedural minimum lumen area by 3D QCA	1 day
Secondary	Post-procedural lumen diameters at the reference segments	Post-procedural lumen diameters at the reference segments by 3D QCA	1 day
Secondary	Post-procedural lumen areas at the reference segments	Post-procedural lumen areas at the reference segments by 3D QCA	1 day
Secondary	Post-procedural volume of the stented segment	Post-procedural volume of the stented segment by 3D QCA	1 day
Secondary	Post-procedural volume of the reference segments	Post-procedural volume of the reference segments by 3D QCA	1 day