The goal of this observational study is to assess the diagnostic performance of 3D Stent to detect stent under-expansion in patients undergoing percutaneous coronary intervention. The main question it aims to answer is: The study hypothesis is that 3DStent technology will offer a comparable assessment of stent expansion compared to intravascular imaging.
Study Type
OBSERVATIONAL
Enrollment
200
Coronary interventions will be performed according to the standard of care, which includes IVUS guidance. In patients undergoing stent implantation, a 3DStent image acquisition will be done followed by IVUS.
AZORG Ziekenhuis
Aalst, Belgium
RECRUITINGICPS
Paris, France
NOT_YET_RECRUITINGI.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy
NOT_YET_RECRUITINGHospital Clinic
Diagnostic performance of 3DStent to detect stent underexpansion with intravascular ultrasound imaging (IVUS) as a reference.
Diagnostic performance will be evaluated in terms of sensitivity and specificity. Intravascular Ultrasound (IVUS)-derived minimal stent area (MSA) ≤ 5.5 mm2 will be used to define stent underexpansion.
Time frame: Periprocedural timeframe
Agreement on minimal stent area (MSA) between 3DStent and Intravascular Ultrasound (IVUS).
Agreement on minimal stent area (MSA), expressed in mm², between 3DStent and Intravascular Ultrasound (IVUS).
Time frame: Periprocedural timeframe
Clinical utility of 3DStent for guiding stent optimisation with Intravascular Ultrasound (IVUS) as a reference.
Clinical utility of 3D stent for guiding stent optimization (i.e. post-dilatation) expressed as a percentage compared with Intravascular Ultrasound (IVUS) as the reference
Time frame: Periprocedural timeframe
Feasibility of 3DStent acquisition during the procedure
Feasibility of 3DStent acquisition during the procedure will be assessed based on the technical success rate.
Time frame: Periprocedural timeframe
Agreement on stent expansion between 3DStent and IVUS.
Agreement on stent expansion, expressed as a percentage between 3DStent and IVUS.
Time frame: Periprocedural timeframe
Impact of lesion location (vessel and segment) on 3DStent diagnostic accuracy.
the impact of the lesion location (location of the vessel and location of the vessel segment) on the diagnostic accuracy of 3D Stent will be assessed.
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Barcelona, Spain
Time frame: Periprocedural timeframe
Agreement on maximal calcium arc as assessed by 3DStent, with IVUS as the reference in cases where 3DStent is acquired pre-PCI.
in cases where 3DStent is also acquired before the PCI procedure, there the agreement on maximal calcium arc will be compared between 3DStent and Intravascular Ultrasound (IVUS).
Time frame: Periprocedural timeframe
Impact of calcifications on 3DStent diagnostic accuracy.
Impact of calcifications on 3DStent diagnostic accuracy (measured as mean difference in Minimal Stent Area between 3DStent and IVUS)
Time frame: Periprocedural timeframe
Agreement on stent underexpansion and MSA between site and core laboratory.
The assessment of stent underexpansion and minimal stent area will be compared between the results of the site and the results of a core laboratory.
Time frame: Periprocedural timeframe
Radiation exposure associated with 3DStent
The dose area product will be measured to assess radiation exposure associated with 3DStent.
Time frame: Periprocedural timeframe
Procedural time of the 3DStent workflow
The duration of the 3DStent acquisition workflow from the beginning of the centering until the 3DStent reconstruction appears on the screen, will be measured
Time frame: Periprocedural timeframe