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Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial - Trial NCT06358105

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.

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NCT06358105
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Trial Details
ClinicalTrials.gov โ€ข NCT06358105
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Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

Study Focus

Coronary Artery Disease

Simulator-based training

Interventional

procedure

Sponsor & Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Timeline & Enrollment

N/A

Nov 15, 2024

Nov 15, 2025

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, unspecified
Atherosclerotic cardiovascular disease, so described
Atherosclerotic heart disease
Abnormal findings on diagnostic imaging of heart and coronary circulation
Coronary vasodilators, not elsewhere classified

Data Source

ClinicalTrials.gov

NCT06358105

Non-Device Trial