The 3D Stent Study

Recruiting now

Conditions studied: Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)

In brief

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.

Key facts

Study ID

NCT06898021

Run by

CoreAalst BV

People needed

200

Starts

2025-04-11

Expected to finish

2027-12-31

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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).

Where it is running

• AZORG Ziekenhuis — Aalst, Belgium (enrolling)
• ICPS — Paris, France
• I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio — Milan, Italy
• Hospital Clinic — Barcelona, Spain

Full record on ClinicalTrials.gov

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