The 3D Stent Study
NCT06898021 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2026-01-12
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.
Conditions
- Coronary Artery Disease
- Percutaneous Coronary Intervention (PCI)
Interventions
- DIAGNOSTIC_TEST
-
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.
Sponsors & Collaborators
-
CoreAalst BV
lead INDUSTRY
Principal Investigators
-
Adriaan Wilgenhof · Cardiovascular Center Aalst
-
Carlos Collet · CoreAalst BV
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-11
- Primary Completion
- 2027-11-01
- Completion
- 2027-12-31
Countries
- Belgium
- France
- Italy
- Spain
Study Locations
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