Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT04862052

Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

Led by Semmelweis University Heart and Vascular Center · Updated on 2024-11-22

150

Participants Needed

2

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR). These are the: * Magic Touch - sirolimus coated balloon * Emperor - paclitaxel and dextran coated balloon * Xience - chromium-cobalt everolimus eluting stent

CONDITIONS

Official Title

Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted for intervention of drug eluting stent restenosis
  • Restenosis suitable for all three treatment arms as per 'instructions for use' of the devices
  • Optional enrollment in the optical coherence tomography sub-study (10-20% of patients)
Not Eligible

You will not qualify if you...

  • Patients undergoing coronary angiography after sudden cardiac death
  • Pregnant or nursing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Semmelweis University Heart and Vascular Center

Budapest, Budapest, Hungary, 1122

Actively Recruiting

2

University of Szeged, Department of Invasive Cardiology

Szeged, Csongád-Csanád, Hungary, 6725

Actively Recruiting

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Research Team

I

István F Édes, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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