Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TEST3DStent
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.
Sponsors
CoreAalst BV
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.
Exclusion criteria
1. Age \<18 years 2. Coronary lesions requiring total stent length \> 48 mm. 3. Body mass index \>35 kg/m2 4. Uncontrolled recurrent ventricular tachycardia 5. Cardiogenic shock 6. Unable to provide written informed consent (IC).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of 3DStent to detect stent underexpansion with intravascular ultrasound imaging (IVUS) as a reference. | Periprocedural timeframe | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical utility of 3DStent for guiding stent optimisation with Intravascular Ultrasound (IVUS) as a reference. | Periprocedural timeframe | 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 |
| Feasibility of 3DStent acquisition during the procedure | Periprocedural timeframe | Feasibility of 3DStent acquisition during the procedure will be assessed based on the technical success rate. |
| Agreement on stent expansion between 3DStent and IVUS. | Periprocedural timeframe | Agreement on stent expansion, expressed as a percentage between 3DStent and IVUS. |
| Impact of lesion location (vessel and segment) on 3DStent diagnostic accuracy. | Periprocedural timeframe | 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. |
| Agreement on minimal stent area (MSA) between 3DStent and Intravascular Ultrasound (IVUS). | Periprocedural timeframe | Agreement on minimal stent area (MSA), expressed in mm², between 3DStent and Intravascular Ultrasound (IVUS). |
| Impact of calcifications on 3DStent diagnostic accuracy. | Periprocedural timeframe | Impact of calcifications on 3DStent diagnostic accuracy (measured as mean difference in Minimal Stent Area between 3DStent and IVUS) |
| Agreement on stent underexpansion and MSA between site and core laboratory. | Periprocedural timeframe | 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. |
| Radiation exposure associated with 3DStent | Periprocedural timeframe | The dose area product will be measured to assess radiation exposure associated with 3DStent. |
| Procedural time of the 3DStent workflow | Periprocedural timeframe | The duration of the 3DStent acquisition workflow from the beginning of the centering until the 3DStent reconstruction appears on the screen, will be measured |
| Agreement on maximal calcium arc as assessed by 3DStent, with IVUS as the reference in cases where 3DStent is acquired pre-PCI. | Periprocedural timeframe | 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). |
Countries
Belgium, France, Italy, Spain
Contacts
Primary ContactSofie Pardaens
Outcome results
None listed