The objective is to assess whether analysis of the initial coronary CTA datasets using AR technology would affect the PCI treatment strategy and its immediate results as compared to traditional PCI under angiographic guidance alone.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) length of the stented segment and (2) predicted stent diameter according to
a compliance chart.
To reduce bias, all study endpoints will be collected in a blinded fashion with
respect to group allocation as well as patients* clinical and tomographic
characteristics.
Secondary outcome
- nominal stent diameter
- number of stents
- predilation
- postdilation
- maximal balloon pressure
- maximal balloon diameter
- total procedural time
- total fluoroscopy time
- total radiation dose
- total contrast load
- procedural complications (including death, myocardial infarction, stroke,
transient ischemic attack, need for urgent CABG, pericardial tamponade,
contrast-induced nephropathy, stent-edge dissection, dissection length)
- post-procedural residual diameter stenosis using 3D QCA
- post-procedural residual area stenosis using 3D QCA
- post-procedural minimum lumen diameter using 3D QCA
- post-procedural minimum lumen area using 3D QCA
- post-procedural lumen diameters at proximal and distal reference segments
using 3D QCA
- post-procedural lumen areas at proximal and distal reference segments using
3D QCA
- post-procedural volume of the stented segment using 3D QCA
- post-procedural volume of the reference segments using 3D QCA
To reduce bias, all study endpoints will be collected in a blinded fashion with
respect to group allocation as well as patients* clinical and tomographic
characteristics.
Background summary
Despite steady advancements in coronary stent technology, percutaneous coronary
intervention (PCI) is still associated with a non-negligible rate of mechanical
complications. Coronary computed tomography angiography (CTA) has emerged as a
valuable non-invasive tool to provide guidance during PCI with a potential for
changing revascularization technique. Recently, the concept of
augmented-reality (AR) in which the PCI operator is supplemented with
additional visual information generated by a hands-free mobile computer
equipped with a head-mounted display (smart glass) has been recognized as a
safe and reliable carrier for CCTA integration to the catheterization
laboratory. To date, there has been no prospective study evaluating the
influence of on-site CTA-assisted PCI using AR technology versus angiography
alone on procedural outcomes in native coronary stenoses.
Study objective
The objective is to assess whether analysis of the initial coronary CTA
datasets using AR technology would affect the PCI treatment strategy and its
immediate results as compared to traditional PCI under angiographic guidance
alone.
Study design
Sixty patients with severe obstructive CAD (*70%) on coronary CTA reffered for
PCI on clinical grounds, will be randomized in a 1:1 fashion to
angiographically plus CTA-assisted PCI or to angiographically-guided PCI. In
patients that did not undergo coronary CTA in the past 3 months, a coronary CTA
will be performed for study purposes. In patients randomized to the
CTA-assisted group the operator will review the CTA datasets of all significant
lesions in the catheterization laboratory using a wearable AR glass to
establish the preliminary PCI strategy. In patients randomized to the
angiography group the operator will be blinded to the CTA data, and PCI will be
performed under standard angiographic guidance alone.
Intervention
Patients will be randomized in a 1:1 fashion to angiographically plus
CTA-assisted PCI or to angiographically-guided PCI only
Study burden and risks
Since coronary angiography and PCI will be performed with a clinical
indication, most patients will not be exposed to additional radiation. However,
patients who will undergo a CTA for study purposes will be exposed to minimal
additional radiation dose (2.1 mSv) and minimal risk of contrast induced
nephropathy and allergic reaction to contrast. Although both the safety and
feasibility of AR technology for projection of CTA datasets to the
catheterization lab have already been tested in prior studies, the effect of
CTA guided PCI with the use of AR technology has yet to be established. The
potential benefit of participation in the trial is that possibly CTA guided PCI
with the use of AR technology will lead to more optimal stent placement,
possibly reducing the risk of in stent restenosis. However, on the hand if PCI
with the use of AR technology leads to suboptimal stent placement, the risk of
restenosis is possible increased.
A second potential benefit is the expected reduction in radiation with the use
of AR technology assisted PCI.
In patients that did not undergo coronary CTA in the past 3 months, a coronary
CTA will be performed for study purposes. These patients will have to visit the
hospital for this scan. The hospital visit will take approximately one and a
half hour. Furthermore, they will be exposed to additional radiation dose of
approximately 2.1 mSv.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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 low
- bifurcation lesions, by which strategies other than a single cross-over stent technique are anticipated (i.e., side branch diameter *2.5 mm)
- left main coronary artery stenosis
- chronic total occlusions (excluding subtotal stenoses)
- in-stent restenosis
- chronic renal failure (estimated glomerular filtration rate <30 ml/min)
- known allergy to contrast
- untreated hyperthyroidism
- pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63928.029.17 |