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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2018-12-31

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.

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Angiographic guided PCI

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

Group Type ACTIVE_COMPARATOR

Angiographic guided PCI

Intervention Type PROCEDURE

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

CTA guided PCI

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

Group Type EXPERIMENTAL

Augmented-Reality CTA guided PCI

Intervention Type PROCEDURE

Augmented-Reality CTA guided PCI is coronary revascularization based on systematic use of CTA datasets displayed in augmented-reality glass plus coronary angiography.

Interventions

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Angiographic guided PCI

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No