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The 3D Stent Study

RECRUITINGSponsored by CoreAalst BV
Actively Recruiting
SponsorCoreAalst BV
Started2025-04-11
Est. completion2027-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06898021

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

Age: 18 Years+Healthy volunteers accepted
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).

Conditions3

Coronary Artery DiseaseHeart DiseasePercutaneous Coronary Intervention (PCI)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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