Status:
NOT_YET_RECRUITING
The 3D Stent Study
Lead Sponsor:
CoreAalst BV
Conditions:
Coronary Artery Disease
Percutaneous Coronary Intervention (PCI)
Eligibility:
All Genders
18+ years
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 i...
Eligibility Criteria
Inclusion
- Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.
Exclusion
- Age \<18 years
- Coronary lesions requiring total stent length \> 48 mm.
- Body mass index \>35 kg/m2
- Uncontrolled recurrent ventricular tachycardia
- Cardiogenic shock
- Unable to provide written informed consent (IC).
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06898021
Start Date
April 1 2025
End Date
December 31 2027
Last Update
March 27 2025
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