Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study (AR-PCI)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Angiographic guided PCI
Augmented-Reality CTA guided PCI
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Stenosis, Percutaneous Coronary Intervention, Stents, Computed Tomography Angiography, Augmented Reality
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
Sites / Locations
- VU University Medical Center AmsterdamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Angiographic guided PCI
CTA guided PCI
Arm Description
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
CTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography.
Outcomes
Primary Outcome Measures
Stent length
Length of the stented segment
Predicted stent diameter
Predicted final stent diameter according to a compliance chart
Secondary Outcome Measures
Nominal stent diameter
Nominal diameter of the implanted stent
Number of stents
Total number of stents
Predilation
Balloon predilation for lesion modification
Postdilation
Balloon postdilation for stent expansion
Maximal balloon pressure
Maximal balloon pressure applied during PCI
Maximal balloon diameter
Maximal balloon diameter applied during PCI
Stent-edge dissection
Stent-edge dissection by coronary angiography
Post-procedural residual diameter stenosis
Post-procedural residual diameter stenosis by 3D QCA
Post-procedural residual area stenosis
Post-procedural residual area stenosis by 3D QCA
Post-procedural minimum lumen diameter
Post-procedural minimum lumen diameter by 3D QCA
Post-procedural minimum lumen area
Post-procedural minimum lumen area by 3D QCA
Post-procedural lumen diameters at the reference segments
Post-procedural lumen diameters at the reference segments by 3D QCA
Post-procedural lumen areas at the reference segments
Post-procedural lumen areas at the reference segments by 3D QCA
Post-procedural volume of the stented segment
Post-procedural volume of the stented segment by 3D QCA
Post-procedural volume of the reference segments
Post-procedural volume of the reference segments by 3D QCA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03531424
Brief Title
Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul Knaapen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Stenosis, Percutaneous Coronary Intervention, Stents, Computed Tomography Angiography, Augmented Reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Angiographic guided PCI
Arm Type
Active Comparator
Arm Description
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
Arm Title
CTA guided PCI
Arm Type
Experimental
Arm Description
CTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography.
Intervention Type
Procedure
Intervention Name(s)
Angiographic guided PCI
Intervention Description
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
Intervention Type
Procedure
Intervention Name(s)
Augmented-Reality CTA guided PCI
Intervention Description
Augmented-Reality CTA guided PCI is coronary revascularization based on systematic use of CTA datasets displayed in augmented-reality glass plus coronary angiography.
Primary Outcome Measure Information:
Title
Stent length
Description
Length of the stented segment
Time Frame
1 day
Title
Predicted stent diameter
Description
Predicted final stent diameter according to a compliance chart
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Nominal stent diameter
Description
Nominal diameter of the implanted stent
Time Frame
1 day
Title
Number of stents
Description
Total number of stents
Time Frame
1 day
Title
Predilation
Description
Balloon predilation for lesion modification
Time Frame
1 day
Title
Postdilation
Description
Balloon postdilation for stent expansion
Time Frame
1 day
Title
Maximal balloon pressure
Description
Maximal balloon pressure applied during PCI
Time Frame
1 day
Title
Maximal balloon diameter
Description
Maximal balloon diameter applied during PCI
Time Frame
1 day
Title
Stent-edge dissection
Description
Stent-edge dissection by coronary angiography
Time Frame
1 day
Title
Post-procedural residual diameter stenosis
Description
Post-procedural residual diameter stenosis by 3D QCA
Time Frame
1 day
Title
Post-procedural residual area stenosis
Description
Post-procedural residual area stenosis by 3D QCA
Time Frame
1 day
Title
Post-procedural minimum lumen diameter
Description
Post-procedural minimum lumen diameter by 3D QCA
Time Frame
1 day
Title
Post-procedural minimum lumen area
Description
Post-procedural minimum lumen area by 3D QCA
Time Frame
1 day
Title
Post-procedural lumen diameters at the reference segments
Description
Post-procedural lumen diameters at the reference segments by 3D QCA
Time Frame
1 day
Title
Post-procedural lumen areas at the reference segments
Description
Post-procedural lumen areas at the reference segments by 3D QCA
Time Frame
1 day
Title
Post-procedural volume of the stented segment
Description
Post-procedural volume of the stented segment by 3D QCA
Time Frame
1 day
Title
Post-procedural volume of the reference segments
Description
Post-procedural volume of the reference segments by 3D QCA
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maksymilian P. Opolski, MD, PhD
Phone
+48501444303
Email
m.opolski@vumc.nl
Facility Information:
Facility Name
VU University Medical Center Amsterdam
City
Amsterdam
State/Province
De Boelelaan 1117
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maksymilian P. Opolski, MD, PhD
Phone
+48501444303
Email
m.opolski@vumc.nl
First Name & Middle Initial & Last Name & Degree
Maksymilian P. Opolski, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study
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