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Clinical Trials in France / NCT06898021
Recruiting Observational

The 3D Stent Study

NCT06898021 · tracked via the Priya Life Science France tracker
Sponsor
CoreAalst BV
Phase
Observational
Started
2025-04-11
Last updated
2026-01-12

Condition(s) studied

Coronary Artery DiseasePercutaneous Coronary Intervention (PCI)

Investigational drug(s) / intervention(s)

3DStent

3DStent: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
AZORG Ziekenhuis Aalst Belgium Recruiting
ICPS Paris France Not Yet Recruiting
I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio Milan Italy Not Yet Recruiting
Hospital Clinic Barcelona Spain Not Yet Recruiting

More CoreAalst BV trials in France

Precise Procedural and PCI Plan (P4) Active, not recruiting
INSIGHTFUL-FFR Clinical Trial Recruiting

Other trials for the same condition

Precise Procedural and PCI Plan (P4) Active, not recruiting
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI Recruiting
Post-Operative Myocardial Incident & Atrial Fibrillation Recruiting
Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation Recruiting
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06898021 on ClinicalTrials.gov ↗ ← All trials in France