Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06898021

The 3D Stent Study

Diagnostic Performance of 3DStent to Assess Stent Expansion

Status
Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
CoreAalst BV · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TEST3DStentCoronary 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.

Timeline

Start date
2025-04-11
Primary completion
2027-11-01
Completion
2027-12-31
First posted
2025-03-27
Last updated
2026-01-12

Locations

4 sites across 4 countries: Belgium, France, Italy, Spain

Source: ClinicalTrials.gov record NCT06898021. Inclusion in this directory is not an endorsement.