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Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

Recruiting
18-85 years
All
Phase N/A

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Overview

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

Eligibility

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study details
    Coronary Stent Restenosis

NCT04862052

Semmelweis University Heart and Vascular Center

1 May 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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