NCT06358105

Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·ClinicalTrials.gov·procedureNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Coronary Artery Disease
Drug/Device/Intervention
Simulator-based training
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Location
Rome, Italy
Timeline & enrollment
Phase
N/A
Start date
Nov 15, 2024
End date
Nov 15, 2025
Enrollment
400 participants
Primary outcome

Mean total fluoroscopy radiation time (expressed in seconds)

Summary

The goal of this clinical trial is to learn if simulator-based training will improve
 interventional cardiology fellows' skills and will improve patient outcomes.
 
 The main questions it aims to answer are:
 
 - Does this training improve specific operative parameters recorded during initial
 coronary interventions performed as first operators under senior supervision?
 
 - Will major and minor procedural complications be reduced after simulator-based training?
 
 Interventional cardiology fellows in their first year of training will be randomized between
 standard master-apprentice training or simulator-based training before starting their cath
 lab period.
 
 They will be supervised during their cath lab period as first operators by senior
 interventional cardiologists.
 
 During their first 50 procedures performed as supervised first operator, specific procedural
 data will be collected.

ICD-10 classifications
Cardiovascular disease, unspecifiedAtherosclerotic cardiovascular disease, so describedAtherosclerotic heart diseaseAbnormal findings on diagnostic imaging of heart and coronary circulationCoronary vasodilators, not elsewhere classified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06358105
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06358105 through Pure Global AI's free database. This phase not specified trial is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and is currently Not yet recruiting. The study focuses on Coronary Artery Disease. Target enrollment is 400 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.