Brief 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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

150

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach

1 country

2 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

First Submitted

Initial submission to the registry

April 20, 2021

Completed

6 days until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed

Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

3.7 years

First QC Date

April 20, 2021

Last Update Submit

November 19, 2024

Conditions

Coronary Stent Restenosis

Keywords

drug eluting stentrestenosisdrug coated balloon

Outcome Measures

Primary Outcomes (3)

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 Outcomes (7)

Percentage late lumen loss
6 months
Percentage intraluminal gain after treatment
index procedure
Square millimetre intraluminal gain after treatment
index procedure
Percentage intraluminal gain after treatment
6 months
Square millimeter intraluminal gain after treatment
6 months
+2 more secondary outcomes

Study Arms (3)

Xience chromium-cobalt everolimus eluting stent

ACTIVE COMPARATOR

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

Emperor paclitaxel coated balloon

EXPERIMENTAL

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

Magic Touch sirolimus coated balloon

EXPERIMENTAL

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

Interventions

Intravascular management of prior implanted coronary drug eluting stent restenosisPROCEDURE

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

Emperor paclitaxel coated balloonMagic Touch sirolimus coated balloonXience chromium-cobalt everolimus eluting stent

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

Patients undergoing coronary angiography after sudden cardiac death
Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Semmelweis University Heart and Vascular Centerlead

Study Sites (2)

Semmelweis University Heart and Vascular Center

Budapest, Budapest, 1122, Hungary

RECRUITING

University of Szeged, Department of Invasive Cardiology

Szeged, Csongád-Csanád, 6725, Hungary

RECRUITING

Related Publications (2)

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.
PMID: 35694680BACKGROUND
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.
PMID: 39997337DERIVED

Study Officials

István F Édes, MD PhD
Semmelweis University Heart and Vascular Center
PRINCIPAL INVESTIGATOR

Central Study Contacts

István F Édes, MD PhD

CONTACT

+3614586810 edes789@gmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 27, 2021

Study Start

April 26, 2021

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing: Will not share

Locations

HU(2)

Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (3)

Xience chromium-cobalt everolimus eluting stent

Emperor paclitaxel coated balloon

Magic Touch sirolimus coated balloon

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (2)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (3)

Xience chromium-cobalt everolimus eluting stent

Emperor paclitaxel coated balloon

Magic Touch sirolimus coated balloon

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (2)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations