3D Stent test to detect stent under-expansion during PCI
Diagnostic Performance of 3DStent to Assess Stent Expansion
This will test whether 3D Stent can detect stent under-expansion as well as intravascular imaging in people having PCI for coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CoreAalst BV Industry-sponsored |
| Locations | 4 sites (Aalst and 3 other locations) |
| Trial ID | NCT06898021 on ClinicalTrials.gov |
What this trial studies
This is an observational, multicenter comparison of the 3DStent imaging technology against intravascular imaging (IVUS) in patients undergoing IVUS-guided percutaneous coronary intervention. Eligible patients present with chronic or acute coronary syndromes and are scheduled for PCI where intravascular imaging will be used. The protocol compares 3DStent measurements of stent expansion to the reference standard intravascular imaging to determine diagnostic agreement. Patients with very long target lesions, high BMI, or unstable hemodynamics are excluded.
Who should consider this trial
Good fit: Adults with chronic or acute coronary syndromes who are scheduled for IVUS-guided PCI and can give informed consent are ideal candidates.
Not a fit: Patients with total stent length requirements over 48 mm, BMI over 35 kg/m2, uncontrolled ventricular tachycardia, cardiogenic shock, or inability to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, 3DStent could offer a faster and less resource-intensive way to identify stent under-expansion and help optimize stent deployment.
How similar studies have performed: 3D angiographic reconstruction approaches have shown promising but variable agreement with intravascular imaging in prior work, so this application is relatively new and requires further validation.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Aalst and 3 other locations
- 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)
Study contacts
- Principal investigator: Adriaan Wilgenhof — Cardiovascular Center Aalst
- Study coordinator: Sofie Pardaens
- Email: sofiepardaens@coreaalst.com
- Phone: 0032 53 72 42 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.