- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531424
Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study (AR-PCI)
May 19, 2018 updated by: Paul Knaapen
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maksymilian P. Opolski, MD, PhD
- Phone Number: +48501444303
- Email: m.opolski@vumc.nl
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Angiographic guided PCI
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
|
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.
|
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
Time Frame: 1 day
|
Length of the stented segment
|
1 day
|
Predicted stent diameter
Time Frame: 1 day
|
Predicted final stent diameter according to a compliance chart
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nominal stent diameter
Time Frame: 1 day
|
Nominal diameter of the implanted stent
|
1 day
|
Number of stents
Time Frame: 1 day
|
Total number of stents
|
1 day
|
Predilation
Time Frame: 1 day
|
Balloon predilation for lesion modification
|
1 day
|
Postdilation
Time Frame: 1 day
|
Balloon postdilation for stent expansion
|
1 day
|
Maximal balloon pressure
Time Frame: 1 day
|
Maximal balloon pressure applied during PCI
|
1 day
|
Maximal balloon diameter
Time Frame: 1 day
|
Maximal balloon diameter applied during PCI
|
1 day
|
Stent-edge dissection
Time Frame: 1 day
|
Stent-edge dissection by coronary angiography
|
1 day
|
Post-procedural residual diameter stenosis
Time Frame: 1 day
|
Post-procedural residual diameter stenosis by 3D QCA
|
1 day
|
Post-procedural residual area stenosis
Time Frame: 1 day
|
Post-procedural residual area stenosis by 3D QCA
|
1 day
|
Post-procedural minimum lumen diameter
Time Frame: 1 day
|
Post-procedural minimum lumen diameter by 3D QCA
|
1 day
|
Post-procedural minimum lumen area
Time Frame: 1 day
|
Post-procedural minimum lumen area by 3D QCA
|
1 day
|
Post-procedural lumen diameters at the reference segments
Time Frame: 1 day
|
Post-procedural lumen diameters at the reference segments by 3D QCA
|
1 day
|
Post-procedural lumen areas at the reference segments
Time Frame: 1 day
|
Post-procedural lumen areas at the reference segments by 3D QCA
|
1 day
|
Post-procedural volume of the stented segment
Time Frame: 1 day
|
Post-procedural volume of the stented segment by 3D QCA
|
1 day
|
Post-procedural volume of the reference segments
Time Frame: 1 day
|
Post-procedural volume of the reference segments by 3D QCA
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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