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

June 27, 2022 updated by: Istvan Edes, Semmelweis University Heart and Vascular Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Semmelweis University Heart and Vascular Center
        • Contact:
    • Csongád-Csanád
      • Szeged, Csongád-Csanád, Hungary, 6725
        • Recruiting
        • University of Szeged, Department of Invasive Cardiology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Xience chromium-cobalt everolimus eluting stent
The Xience chromium-cobalt everolimus eluting stent will be evaluated in prior implanted coronary drug eluting stent restenosis.
Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis
Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.
Experimental: Emperor paclitaxel coated balloon
The Emperor paclitaxel coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.
Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis
Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.
Experimental: Magic Touch sirolimus coated balloon
The Magic Touch sirolimus coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.
Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis
Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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.
6 months
Occurrence of target lesion revascularization
Time Frame: 6 months
The need for further revascularization of the target lesion after treatment with either study device.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage late lumen loss
Time Frame: 6 months
Late lumen loss measured via qualitative coronary angiography in treated segment(s)
6 months
Percentage intraluminal gain after treatment
Time Frame: index procedure
Intraluminal gain after assigned treatment measured via optical coherence tomography
index procedure
Square millimetre intraluminal gain after treatment
Time Frame: index procedure
Intraluminal gain after assigned treatment measured via optical coherence tomography
index procedure
Percentage intraluminal gain after treatment
Time Frame: 6 months
Intraluminal gain after assigned treatment measured via optical coherence tomography
6 months
Square millimeter intraluminal gain after treatment
Time Frame: 6 months
Intraluminal gain after assigned treatment measured via optical coherence tomography
6 months
Endothelium coverage in micrometers
Time Frame: 6 months
Mean endothelium thickness of stent struts in micrometres measured via optical coherence tomography
6 months
Late lumen loss in square millimetres
Time Frame: 6 months
Late lumen loss in square millimetres measured via optical coherence tomography
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Investigators

  • Principal Investigator: István F Édes, MD PhD, Semmelweis University Heart and Vascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OPEN ISR - 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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