The 3D Stent Study
Condition(s) studied
Investigational drug(s) / intervention(s)
3DStent: 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.
Study 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.
Eligibility
Primary outcome measure(s)
- 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.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| AZORG Ziekenhuis | Aalst | Belgium | Recruiting |
| ICPS | Paris | France | Not Yet Recruiting |
| I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio | Milan | Italy | Not Yet Recruiting |
| Hospital Clinic | Barcelona | Spain | Not Yet Recruiting |
More CoreAalst BV trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06898021 on ClinicalTrials.gov ↗ ← All trials in Spain