Clinical trial NCT03531424: Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study
Official title: On-Site Augmented-Reality Computed Tomography Plus Angiography Versus Angiography Alone for Guiding Percutaneous Coronary Intervention in Native Coronary Lesions - Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Stenosis
Percutaneous Coronary Intervention
Stents
Computed Tomography Angiography
Augmented Reality
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stent length
timeFrame: 1 day
measure: Predicted stent diameter
timeFrame: 1 day
Secondary outcomes:
measure: Nominal stent diameter
timeFrame: 1 day
measure: Number of stents
timeFrame: 1 day
measure: Predilation
timeFrame: 1 day
measure: Postdilation
timeFrame: 1 day
measure: Maximal balloon pressure
timeFrame: 1 day
measure: Maximal balloon diameter
timeFrame: 1 day
measure: Stent-edge dissection
timeFrame: 1 day
measure: Post-procedural residual diameter stenosis
timeFrame: 1 day
measure: Post-procedural residual area stenosis
timeFrame: 1 day
measure: Post-procedural minimum lumen diameter
timeFrame: 1 day
measure: Post-procedural minimum lumen area
timeFrame: 1 day
measure: Post-procedural lumen diameters at the reference segments
timeFrame: 1 day
measure: Post-procedural lumen areas at the reference segments
timeFrame: 1 day
measure: Post-procedural volume of the stented segment
timeFrame: 1 day
measure: Post-procedural volume of the reference segments
timeFrame: 1 day
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center Amsterdam
state: De Boelelaan 1117
Study officials:
References: