Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis (OPEN-ISR)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    150
  • sponsor
    Semmelweis University Heart and Vascular Center
Updated on 8 July 2022

Summary

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

Details
Condition Coronary Stent Restenosis
Treatment Intravascular management of prior implanted coronary drug eluting stent restenosis
Clinical Study IdentifierNCT04862052
SponsorSemmelweis University Heart and Vascular Center
Last Modified on8 July 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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