RecruitingNCT06898021

The 3D Stent Study

Diagnostic Performance of 3DStent to Assess Stent Expansion

Sponsor

CoreAalst BV

Enrollment

200 participants

Start Date

Apr 11, 2025

Study Type

OBSERVATIONAL

Conditions

Coronary Artery Disease Percutaneous Coronary Intervention (PCI)

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

Min Age: 18 Years

Inclusion Criteria1

Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.

Exclusion Criteria6

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).

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Interventions

DIAGNOSTIC_TEST3DStent

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.