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

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: Completed
• Conditions: Coronary Stent Restenosis
• Intervention / Treatment: Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

3

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	New onset myocardial infarction that affects the target vessel treated with either study device	6 months
Occurrence of target vessel revascularization of failure	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	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	Late lumen loss measured via qualitative coronary angiography in treated segment(s)	6 months
Percentage intraluminal gain after treatment	Intraluminal gain after assigned treatment measured via optical coherence tomography	index procedure
Square millimetre intraluminal gain after treatment	Intraluminal gain after assigned treatment measured via optical coherence tomography	index procedure
Percentage intraluminal gain after treatment	Intraluminal gain after assigned treatment measured via optical coherence tomography	6 months
Square millimeter intraluminal gain after treatment	Intraluminal gain after assigned treatment measured via optical coherence tomography	6 months
Endothelium coverage in micrometers	Mean endothelium thickness of stent struts in micrometres measured via optical coherence tomography	6 months
Late lumen loss in square millimetres	Late lumen loss in square millimetres measured via optical coherence tomography	6 months

Collaborators and Investigators

• 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

General Publications

• Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022.
• Kulyassa PM, Nemeth BT, Hizoh I, Janko LK, Ruzsa Z, Jambrik Z, Balazs BB, Becker D, Merkely B, Edes IF. The Design and Feasibility of Optimal Treatment for Coronary Drug-Eluting Stent In-Stent Restenosis (OPEN-ISR)-A Prospective, Randomised, Multicentre Clinical Trial. J Pers Med. 2025 Feb 2;15(2):60. doi: 10.3390/jpm15020060.

Helpful Links

• Link to design and feasibility manuscript

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 30, 2025

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): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: drug eluting stent; drug coated balloon; restenosis
• 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
• product manufactured in and exported from the U.S.: No