The 3D Stent Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3DStent.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Percutaneous Coronary Intervention (PCI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, France, Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diagnostic Performance of 3DStent to Assess Stent Expansion
Overview
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.
Interventions
- Diagnostic test 3DStent
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 outcome measures
- Diagnostic performance of 3DStent to detect stent underexpansion with intravascular ultrasound imaging (IVUS) as a reference. [Time frame: Periprocedural timeframe]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- AZORG Ziekenhuis — Aalst
France · 1 center
- ICPS — Paris
Italy · 1 center
- I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio — Milan
Spain · 1 center
- Hospital Clinic — Barcelona
Identifiers
NCT: NCT06898021 · CA-1013