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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing PCI | Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3DStent | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Periprocedural timeframe |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Periprocedural timeframe |
| Clinical utility of 3DStent for guiding stent optimisation with Intravascular Ultrasound (IVUS) as a reference. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting with chronic or acute coronary syndromes (ACS) and a clinical indication for PCI
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofie Pardaens | Contact | 0032 53 72 42 30 | sofiepardaens@coreaalst.com |
| Name | Affiliation | Role |
|---|---|---|
| Adriaan Wilgenhof | Cardiovascular Center Aalst | Principal Investigator |
| Carlos Collet | CoreAalst BV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZORG Ziekenhuis | Recruiting | Aalst | Belgium |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| 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. | Periprocedural timeframe |
| Agreement on stent expansion between 3DStent and IVUS. | Agreement on stent expansion, expressed as a percentage between 3DStent and IVUS. | 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. | 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). | 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) | 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. | Periprocedural timeframe |
| Radiation exposure associated with 3DStent | The dose area product will be measured to assess radiation exposure associated with 3DStent. | 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 | Periprocedural timeframe |
| ICPS | Not yet recruiting | Paris | France |
|
| I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio | Not yet recruiting | Milan | Italy |
|
| Hospital Clinic | Not yet recruiting | Barcelona | Spain |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |