Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06898021

The 3D Stent Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention (PCI) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZORG Ziekenhuis, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.

Exclusion criteria

  • 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).

Treatment and study plan

3DStent

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Agreement on minimal stent area (MSA) between 3DStent and Intravascular Ultrasound (IVUS).

    Time frame: Periprocedural timeframe

    Agreement on minimal stent area (MSA), expressed in mm², between 3DStent and Intravascular Ultrasound (IVUS).

  2. Clinical utility of 3DStent for guiding stent optimisation with Intravascular Ultrasound (IVUS) as a reference.

    Time frame: Periprocedural timeframe

    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

  3. Feasibility of 3DStent acquisition during the procedure

    Time frame: Periprocedural timeframe

    Feasibility of 3DStent acquisition during the procedure will be assessed based on the technical success rate.

  4. Agreement on stent expansion between 3DStent and IVUS.

    Time frame: Periprocedural timeframe

    Agreement on stent expansion, expressed as a percentage between 3DStent and IVUS.

  5. Impact of lesion location (vessel and segment) on 3DStent diagnostic accuracy.

    Time frame: Periprocedural timeframe

    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.

  6. 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

    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).

  7. Impact of calcifications on 3DStent diagnostic accuracy.

    Time frame: Periprocedural timeframe

    Impact of calcifications on 3DStent diagnostic accuracy (measured as mean difference in Minimal Stent Area between 3DStent and IVUS)

  8. Agreement on stent underexpansion and MSA between site and core laboratory.

    Time frame: Periprocedural timeframe

    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.

  9. Radiation exposure associated with 3DStent

    Time frame: Periprocedural timeframe

    The dose area product will be measured to assess radiation exposure associated with 3DStent.

  10. Procedural time of the 3DStent workflow

    Time frame: Periprocedural timeframe

    The duration of the 3DStent acquisition workflow from the beginning of the centering until the 3DStent reconstruction appears on the screen, will be measured

Study contacts

Contact information is provided by the study sponsor or research team.

Sofie Pardaens

CONTACT

[email protected]

0032 53 72 42 30

Sponsors and collaborators

Lead sponsor

CoreAalst BV

Industry

Registry information

Official study title

Diagnostic Performance of 3DStent to Assess Stent Expansion

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.