Coronary Artery DiseaseNCT06898021
The 3D Stent Study
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by CoreAalst BV at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
- What is being tested?
- 3DStent
- How many people
- 200 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 11 Apr 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with chronic or acute coronary syndromes (ACS) and a clinical indication for PCI
Who may be able to join
- Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.
Who cannot join
- Age <18 years
- Coronary lesions requiring total stent length > 48 mm.
- Body mass index >35 kg/m2
- Uncontrolled recurrent ventricular tachycardia
- Cardiogenic shock
- Unable to provide written informed consent (IC).
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Belgium1 site, 1 recruiting
- Recruiting
AZORG Ziekenhuis
Aalst
Adriaan Wilgenhof, adriaan.wilgenhof@azorg.be
France1 site, 1 recruiting
- Not yet recruiting
ICPS
Paris
Nicolas Amabile, nicolasamabile@yahoo.fr
Italy1 site, 1 recruiting
- Not yet recruiting
I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio
Milan
Dario Pellegrini, dar.pellegrini@gmail.com
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Clinic
Barcelona
Salvatore Brugaletta, SABRUGAL@clinic.cat
About this study
Official title: Diagnostic Performance of 3DStent to Assess Stent Expansion
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.
- Being tested
- 3DStent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DStentDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Patients undergoing PCI | Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI Receives: Diagnostic Test: 3DStent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of 3DStent to detect stent underexpansion with intravascular ultrasound imaging (IVUS) as a reference.
Diagnostic performance will be evaluated in terms of sensitivity and specificity. Intravascular Ultrasound (IVUS)-derived minimal stent area (MSA) ≤ 5.5 mm2 will be used to define stent underexpansion.
Measured: Periprocedural timeframe
Secondary outcomes (10)
Agreement on minimal stent area (MSA) between 3DStent and Intravascular Ultrasound (IVUS).
Agreement on minimal stent area (MSA), expressed in mm², between 3DStent and Intravascular Ultrasound (IVUS).
Measured: Periprocedural timeframe
Clinical utility of 3DStent for guiding stent optimisation with Intravascular Ultrasound (IVUS) as a reference.
Clinical utility of 3D stent for guiding stent optimization (i.e. post-dilatation) expressed as a percentage compared with Intravascular Ultrasound (IVUS) as the reference
Measured: Periprocedural timeframe
Feasibility of 3DStent acquisition during the procedure
Feasibility of 3DStent acquisition during the procedure will be assessed based on the technical success rate.
Measured: Periprocedural timeframe
Agreement on stent expansion between 3DStent and IVUS.
Agreement on stent expansion, expressed as a percentage between 3DStent and IVUS.
Measured: Periprocedural timeframe
Impact of lesion location (vessel and segment) on 3DStent diagnostic accuracy.
the impact of the lesion location (location of the vessel and location of the vessel segment) on the diagnostic accuracy of 3D Stent will be assessed.
Measured: Periprocedural timeframe
Agreement on maximal calcium arc as assessed by 3DStent, with IVUS as the reference in cases where 3DStent is acquired pre-PCI.
in cases where 3DStent is also acquired before the PCI procedure, there the agreement on maximal calcium arc will be compared between 3DStent and Intravascular Ultrasound (IVUS).
Measured: Periprocedural timeframe
Impact of calcifications on 3DStent diagnostic accuracy.
Impact of calcifications on 3DStent diagnostic accuracy (measured as mean difference in Minimal Stent Area between 3DStent and IVUS)
Measured: Periprocedural timeframe
Agreement on stent underexpansion and MSA between site and core laboratory.
The assessment of stent underexpansion and minimal stent area will be compared between the results of the site and the results of a core laboratory.
Measured: Periprocedural timeframe
Radiation exposure associated with 3DStent
The dose area product will be measured to assess radiation exposure associated with 3DStent.
Measured: Periprocedural timeframe
Procedural time of the 3DStent workflow
The duration of the 3DStent acquisition workflow from the beginning of the centering until the 3DStent reconstruction appears on the screen, will be measured
Measured: Periprocedural timeframe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start11 Apr 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoreAalst BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adriaan Wilgenhof, Principal investigator, Cardiovascular Center AalstCarlos Collet, Principal investigator, CoreAalst BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898021
- Sponsor's protocol ID
- CA-1013
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of 3DStent to Assess Stent Expansion
- ClinicalTrials.gov ID
- NCT06898021
- Acronym / sponsor ID
- CA-1013
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CoreAalst BVIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing PCI | – | Diagnostic Test: 3DStentPatient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with chronic or acute coronary syndromes (ACS) and a clinical indication for PCI
Key inclusion criteria (1 listed)
- Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.
Key exclusion criteria (6 listed)
- Age <18 years
- Coronary lesions requiring total stent length > 48 mm.
- Body mass index >35 kg/m2
- Uncontrolled recurrent ventricular tachycardia
- Cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3DStentCoronary 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. | Diagnostic test | Patients undergoing PCI |
Primary outcome
Diagnostic performance of 3DStent to detect stent underexpansion with intravascular ultrasound imaging (IVUS) as a reference.
Time frame: Periprocedural timeframe
Diagnostic performance will be evaluated in terms of sensitivity and specificity. Intravascular Ultrasound (IVUS)-derived minimal stent area (MSA) ≤ 5.5 mm2 will be used to define stent underexpansion.
10 secondary outcomes
Agreement on minimal stent area (MSA) between 3DStent and Intravascular Ultrasound (IVUS).
Time frame: Periprocedural timeframe
Clinical utility of 3DStent for guiding stent optimisation with Intravascular Ultrasound (IVUS) as a reference.
Time frame: Periprocedural timeframe
Feasibility of 3DStent acquisition during the procedure
Time frame: Periprocedural timeframe
Agreement on stent expansion between 3DStent and IVUS.
Time frame: Periprocedural timeframe
Impact of lesion location (vessel and segment) on 3DStent diagnostic accuracy.
Time frame: Periprocedural timeframe
Agreement on maximal calcium arc as assessed by 3DStent, with IVUS as the reference in cases where 3DStent is acquired pre-PCI.
Time frame: Periprocedural timeframe
Impact of calcifications on 3DStent diagnostic accuracy.
Time frame: Periprocedural timeframe
Agreement on stent underexpansion and MSA between site and core laboratory.
Time frame: Periprocedural timeframe
Radiation exposure associated with 3DStent
Time frame: Periprocedural timeframe
Procedural time of the 3DStent workflow
Time frame: Periprocedural timeframe
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adriaan Wilgenhof principal investigator
Cardiovascular Center Aalst
Carlos Collet principal investigator
CoreAalst BV
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by CoreAalst BV at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofie Pardaens (0032 53 72 42 30, sofiepardaens@coreaalst.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of 3DStent to detect stent underexpansion with intravascular ultrasound imaging (IVUS) as a reference. (time frame: Periprocedural timeframe). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.