NCT06898021

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
4 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Apr 2025Dec 2027

First Submitted

Initial submission to the registry

January 22, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

January 22, 2025

Last Update Submit

January 9, 2026

Conditions

Percutaneous Coronary Intervention (PCI)Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Periprocedural timeframe

Secondary Outcomes (10)

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

    Periprocedural timeframe

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

    Periprocedural timeframe

  • Feasibility of 3DStent acquisition during the procedure

    Periprocedural timeframe

  • Agreement on stent expansion between 3DStent and IVUS.

    Periprocedural timeframe

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

    Periprocedural timeframe

  • +5 more secondary outcomes

Study Arms (1)

Patients undergoing PCI

Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI

Diagnostic Test: 3DStent

Interventions

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.

Patients undergoing PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting with chronic or acute coronary syndromes (ACS) and a clinical indication for PCI

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Adriaan Wilgenhof

    Cardiovascular Center Aalst

    PRINCIPAL INVESTIGATOR

  • Carlos Collet

    CoreAalst BV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Pardaens

CONTACT

0032 53 72 42 30sofiepardaens@coreaalst.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

March 27, 2025

Study Start

April 11, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)BE(1)IT(1)ES(1)