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ClinicalTrials.gov ID

NCT06898021

Lead Sponsor

CoreAalst BVINDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

200Estimated

Last Update Posted

Jan 12, 2026Actual

Start Date

Apr 11, 2025Actual

Primary Completion Date

Nov 1, 2027Estimated

Completion Date

Dec 31, 2027Estimated

Official Title

Diagnostic Performance of 3DStent to Assess Stent Expansion

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.

• Coronary Artery Disease
• Percutaneous Coronary Intervention (PCI)

• 3DStent

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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).

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

CoreAalst BVINDUSTRY

nicolasamabile@yahoo.fr