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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Angiographic guided PCI; Procedure: Augmented-Reality CTA guided PCI

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • De Boelelaan 1117
    • Amsterdam, De Boelelaan 1117, Netherlands, 1081 HV
      • Recruiting
      • VU University Medical Center Amsterdam
      • Contact: Maksymilian P. Opolski, MD, PhD; Phone Number: +48501444303; Email: m.opolski@vumc.nl
      • Sub-Investigator: Maksymilian P. Opolski, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angiographic guided PCI; Angiographic guided PCI is coronary revascularization based on stand-alone angiography.	Procedure: Angiographic guided PCI; Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
Experimental: CTA guided PCI; CTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent length	Length of the stented segment	1 day
Predicted stent diameter	Predicted final stent diameter according to a compliance chart	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nominal stent diameter	Nominal diameter of the implanted stent	1 day
Number of stents	Total number of stents	1 day
Predilation	Balloon predilation for lesion modification	1 day
Postdilation	Balloon postdilation for stent expansion	1 day
Maximal balloon pressure	Maximal balloon pressure applied during PCI	1 day
Maximal balloon diameter	Maximal balloon diameter applied during PCI	1 day
Stent-edge dissection	Stent-edge dissection by coronary angiography	1 day
Post-procedural residual diameter stenosis	Post-procedural residual diameter stenosis by 3D QCA	1 day
Post-procedural residual area stenosis	Post-procedural residual area stenosis by 3D QCA	1 day
Post-procedural minimum lumen diameter	Post-procedural minimum lumen diameter by 3D QCA	1 day
Post-procedural minimum lumen area	Post-procedural minimum lumen area by 3D QCA	1 day
Post-procedural lumen diameters at the reference segments	Post-procedural lumen diameters at the reference segments by 3D QCA	1 day
Post-procedural lumen areas at the reference segments	Post-procedural lumen areas at the reference segments by 3D QCA	1 day
Post-procedural volume of the stented segment	Post-procedural volume of the stented segment by 3D QCA	1 day
Post-procedural volume of the reference segments	Post-procedural volume of the reference segments by 3D QCA	1 day

Collaborators and Investigators

• Sponsor: Paul Knaapen

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 19, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Stents; Percutaneous Coronary Intervention; Augmented Reality; Coronary Stenosis; Computed Tomography Angiography
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: NL63928.029.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No