| NCT ID | NCT06898021 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CoreAalst BV |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-04-11 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-04-11 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Adriaan Wilgenhof
PRINCIPAL INVESTIGATOR
Cardiovascular Center Aalst
Frequently Asked Questions
Who can join the NCT06898021 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06898021 currently recruiting?
Yes, NCT06898021 is actively recruiting participants. Contact the research team at sofiepardaens@coreaalst.com for enrollment information.
Where is the NCT06898021 trial being conducted?
This trial is being conducted at Aalst, Belgium, Paris, France, Milan, Italy, Barcelona, Spain.
Who is sponsoring the NCT06898021 clinical trial?
NCT06898021 is sponsored by CoreAalst BV. The principal investigator is Adriaan Wilgenhof at Cardiovascular Center Aalst. The trial plans to enroll 200 participants.