3D Stent test to detect stent under-expansion during PCI
Official title: Diagnostic Performance of 3DStent to Assess Stent Expansion
Run by CoreAalst BV · NCT06898021 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | CoreAalst BV Industry-sponsored |
| Locations | 4 sites (Aalst and 3 other locations) |
| Status | Recruiting |
| Started | April 11, 2025 |
| Main results expected | November 1, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT06898021 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with chronic or acute coronary syndromes who are scheduled for IVUS-guided PCI and can give informed consent are ideal candidates.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Cold-region exposure and heart remodeling after PCI
This study tests whether long-term cold exposure before PCI is linked to worse heart remodeling and outcomes in people with coronary artery disease.
-
Best way to fix under‑expanded coronary stents in resistant blockages
This compares intravascular lithotripsy (IVL) with high‑pressure or specialty balloons to see if IVL opens under‑expanded coronary stents better in people with in‑stent restenosis.
-
Hybrid PCI using a magnesium bioresorbable scaffold plus drug-coated balloons versus drug-eluting stents for long, diffuse coronary artery disease
It will test whether combining a magnesium bioresorbable scaffold with paclitaxel drug-coated balloons works as well as newer drug-eluting stents for people with long or diffuse coronary artery blockages who need PCI.
-
Comparing two types of drug-eluting stents for heart procedures
This study is testing whether a new type of heart stent with a thinner design works better and is safer than a traditional stent for patients with blocked arteries.
-
μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease
This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.
-
Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents
This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.