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OpenTrials
Completed

NCT Number: NCT04862052

Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

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

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Key information

Conditions

Coronary Stent Restenosis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University Heart and Vascular Center, Budapest, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravascular management of prior implanted coronary drug eluting stent restenosis

Procedure

Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.

Primary outcomes

  1. Occurrence of new onset target vessel myocardial infarction

    Time frame: 6 months

    New onset myocardial infarction that affects the target vessel treated with either study device

  2. Occurrence of target vessel revascularization of failure

    Time frame: 6 months

    The need for further revascularization affecting the target vessel treated with either study device, or the failure of the vessel treated by either study device.

  3. Occurrence of target lesion revascularization

    Time frame: 6 months

    The need for further revascularization of the target lesion after treatment with either study device.

Secondary outcomes

  1. Percentage late lumen loss

    Time frame: 6 months

    Late lumen loss measured via qualitative coronary angiography in treated segment(s)

  2. Percentage intraluminal gain after treatment

    Time frame: index procedure

    Intraluminal gain after assigned treatment measured via optical coherence tomography

  3. Square millimetre intraluminal gain after treatment

    Time frame: index procedure

    Intraluminal gain after assigned treatment measured via optical coherence tomography

  4. Percentage intraluminal gain after treatment

    Time frame: 6 months

    Intraluminal gain after assigned treatment measured via optical coherence tomography

  5. Square millimeter intraluminal gain after treatment

    Time frame: 6 months

    Intraluminal gain after assigned treatment measured via optical coherence tomography

  6. Endothelium coverage in micrometers

    Time frame: 6 months

    Mean endothelium thickness of stent struts in micrometres measured via optical coherence tomography

  7. Late lumen loss in square millimetres

    Time frame: 6 months

    Late lumen loss in square millimetres measured via optical coherence tomography

Sponsors and collaborators

Lead sponsor

Semmelweis University Heart and Vascular Center

Other

Registry information

Official study title

OPtimal trEatment for coroNary Drug Eluting Stent In-Stent Restenosis: Paclitaxel Versus Sirolimus Coated Balloons Versus Everolimus Eluting Stents - The OPEN ISR Study

Acronym: OPEN-ISR

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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