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

Paul Knaapen

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Procedure: Angiographic guided PCI; Procedure: Augmented-Reality CTA guided PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT03531424

NL63928.029.17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Angiographic guided PCI

Active Comparator group

Description:

Angiographic guided PCI is coronary revascularization based on stand-alone angiography.

Treatment:

Procedure: Angiographic guided PCI

CTA guided PCI

Experimental group

Description:

CTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography.

Treatment:

Procedure: Augmented-Reality CTA guided PCI