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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531424
Recruitment Status : Unknown
Verified May 2018 by Paul Knaapen, VU University Medical Center.
Recruitment status was:  Recruiting
First Posted : May 21, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Knaapen, VU University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Angiographic guided PCI Procedure: Augmented-Reality CTA guided PCI Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: On-Site Augmented-Reality Computed Tomography Plus Angiography Versus Angiography Alone for Guiding Percutaneous Coronary Intervention in Native Coronary Lesions - Randomized Study
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Stent length [ Time Frame: 1 day ]
    Length of the stented segment

  2. Predicted stent diameter [ Time Frame: 1 day ]
    Predicted final stent diameter according to a compliance chart


Secondary Outcome Measures :
  1. Nominal stent diameter [ Time Frame: 1 day ]
    Nominal diameter of the implanted stent

  2. Number of stents [ Time Frame: 1 day ]
    Total number of stents

  3. Predilation [ Time Frame: 1 day ]
    Balloon predilation for lesion modification

  4. Postdilation [ Time Frame: 1 day ]
    Balloon postdilation for stent expansion

  5. Maximal balloon pressure [ Time Frame: 1 day ]
    Maximal balloon pressure applied during PCI

  6. Maximal balloon diameter [ Time Frame: 1 day ]
    Maximal balloon diameter applied during PCI

  7. Stent-edge dissection [ Time Frame: 1 day ]
    Stent-edge dissection by coronary angiography

  8. Post-procedural residual diameter stenosis [ Time Frame: 1 day ]
    Post-procedural residual diameter stenosis by 3D QCA

  9. Post-procedural residual area stenosis [ Time Frame: 1 day ]
    Post-procedural residual area stenosis by 3D QCA

  10. Post-procedural minimum lumen diameter [ Time Frame: 1 day ]
    Post-procedural minimum lumen diameter by 3D QCA

  11. Post-procedural minimum lumen area [ Time Frame: 1 day ]
    Post-procedural minimum lumen area by 3D QCA

  12. Post-procedural lumen diameters at the reference segments [ Time Frame: 1 day ]
    Post-procedural lumen diameters at the reference segments by 3D QCA

  13. Post-procedural lumen areas at the reference segments [ Time Frame: 1 day ]
    Post-procedural lumen areas at the reference segments by 3D QCA

  14. Post-procedural volume of the stented segment [ Time Frame: 1 day ]
    Post-procedural volume of the stented segment by 3D QCA

  15. Post-procedural volume of the reference segments [ Time Frame: 1 day ]
    Post-procedural volume of the reference segments by 3D QCA


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531424


Contacts
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Contact: Maksymilian P. Opolski, MD, PhD +48501444303 m.opolski@vumc.nl

Locations
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Netherlands
VU University Medical Center Amsterdam Recruiting
Amsterdam, De Boelelaan 1117, Netherlands, 1081 HV
Contact: Maksymilian P. Opolski, MD, PhD    +48501444303    m.opolski@vumc.nl   
Sub-Investigator: Maksymilian P. Opolski, MD, PhD         
Sponsors and Collaborators
Paul Knaapen
More Information
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Responsible Party: Paul Knaapen, Clinical Professor, VU University Medical Center
ClinicalTrials.gov Identifier: NCT03531424    
Other Study ID Numbers: NL63928.029.17
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Knaapen, VU University Medical Center:
Coronary Stenosis
Percutaneous Coronary Intervention
Stents
Computed Tomography Angiography
Augmented Reality
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases