The 3D Stent Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCoreAalst BV
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.
Disqualifiers
Age <18 years
Coronary lesions requiring total stent length > 48 mm.
Body mass index >35 kg/m2
Uncontrolled recurrent ventricular tachycardia
Trial population
Patients presenting with chronic or acute coronary syndromes (ACS) and a clinical indication for PCI
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
3DStent
Diagnostic testCoronary 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients undergoing PCI1 intervention
Trial outcomes
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.
Time frame
Periprocedural timeframeSecondary outcomes
1
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).
Time frame
Periprocedural timeframe2
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
Time frame
Periprocedural timeframe3
Feasibility of 3DStent acquisition during the procedure
Feasibility of 3DStent acquisition during the procedure will be assessed based on the technical success rate.
Time frame
Periprocedural timeframe4
Agreement on stent expansion between 3DStent and IVUS.
Agreement on stent expansion, expressed as a percentage between 3DStent and IVUS.
Time frame
Periprocedural timeframeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov