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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Apr 2018
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2018
CompletedFirst Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 22, 2018
May 1, 2018
4 months
May 8, 2018
May 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stent length
Length of the stented segment
1 day
Predicted stent diameter
Predicted final stent diameter according to a compliance chart
1 day
Secondary Outcomes (15)
Nominal stent diameter
1 day
Number of stents
1 day
Predilation
1 day
Postdilation
1 day
Maximal balloon pressure
1 day
- +10 more secondary outcomes
Study Arms (2)
Angiographic guided PCI
ACTIVE COMPARATORAngiographic guided PCI is coronary revascularization based on stand-alone angiography.
CTA guided PCI
EXPERIMENTALCTA guided PCI is coronary revascularization based on systematic use of CTA plus coronary angiography.
Interventions
Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
Augmented-Reality CTA guided PCI is coronary revascularization based on systematic use of CTA datasets displayed in augmented-reality glass plus coronary angiography.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paul Knaapenlead
Study Sites (1)
VU University Medical Center Amsterdam
Amsterdam, De Boelelaan 1117, 1081 HV, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
May 8, 2018
First Posted
May 21, 2018
Study Start
April 25, 2018
Primary Completion
September 1, 2018
Study Completion
December 1, 2018
Last Updated
May 22, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share