Coronary Stent RestenosisOPEN-ISRNCT04862052
Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis
A study testing Intravascular management of prior implanted coronary drug eluting stent restenosis in people with Coronary Stent Restenosis, run by Semmelweis University Heart and Vascular Center at 2 sites in Hungary.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Stent Restenosis
- What is being tested?
- Intravascular management of prior implanted coronary drug eluting stent restenosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesHungary
- Study dates
- 26 Apr 2021to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients undergoing coronary angiography after sudden cardiac death
- Pregnant or nursing
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Semmelweis University Heart and Vascular Center
Budapest, Budapest, 1122
University of Szeged, Department of Invasive Cardiology
Szeged, Csongád-Csanád, 6725
About this study
Official title: 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
- Conditions
- Coronary Stent Restenosis
- Being tested
- Intravascular management of prior implanted coronary drug eluting stent restenosis
- Keywords
- drug eluting stent, restenosis, drug coated balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular management of prior implanted coronary drug eluting stent restenosisProcedure or surgery
Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of new onset target vessel myocardial infarction
New onset myocardial infarction that affects the target vessel treated with either study device
Measured: 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.
Measured: 6 months
Occurrence of target lesion revascularization
The need for further revascularization of the target lesion after treatment with either study device.
Measured: 6 months
Secondary outcomes (7)
Percentage late lumen loss
Late lumen loss measured via qualitative coronary angiography in treated segment(s)
Measured: 6 months
Percentage intraluminal gain after treatment
Intraluminal gain after assigned treatment measured via optical coherence tomography
Measured: index procedure
Square millimetre intraluminal gain after treatment
Intraluminal gain after assigned treatment measured via optical coherence tomography
Measured: index procedure
Percentage intraluminal gain after treatment
Intraluminal gain after assigned treatment measured via optical coherence tomography
Measured: 6 months
Square millimeter intraluminal gain after treatment
Intraluminal gain after assigned treatment measured via optical coherence tomography
Measured: 6 months
Endothelium coverage in micrometers
Mean endothelium thickness of stent struts in micrometres measured via optical coherence tomography
Measured: 6 months
Late lumen loss in square millimetres
Late lumen loss in square millimetres measured via optical coherence tomography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start26 Apr 2021
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Stent RestenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Istvan Edes, Semmelweis University Heart and Vascular Center
- Investigators
- István F Édes, MD PhD, Principal investigator, Semmelweis University Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862052
- Sponsor's protocol ID
- OPEN ISR - 001
- Acronym
- OPEN-ISR
- Status last verified
- May 2026
- First submitted
- 20 Apr 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35694680Kulyassa 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.
PubMed 39997337
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimal trEatment for coroNary Drug Eluting Stent In-Stent Restenosis: Paclitaxel Versus Sirolimus Coated Balloons Versus Everolimus Eluting Stents - The OPEN ISR Study
- ClinicalTrials.gov ID
- NCT04862052
- Acronym / sponsor ID
- OPEN-ISR / OPEN ISR - 001
- Conditions
- Coronary Stent Restenosis
- Keywords
- drug eluting stent, restenosis, drug coated balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xience chromium-cobalt everolimus eluting stent | Active comparator | Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosisThe Xience chromium-cobalt everolimus eluting stent will be evaluated in prior implanted coronary drug eluting stent restenosis. |
| Emperor paclitaxel coated balloon | Experimental | Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosisThe Emperor paclitaxel coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis. |
| Magic Touch sirolimus coated balloon | Experimental | Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosisThe Magic Touch sirolimus coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients undergoing coronary angiography after sudden cardiac death
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular management of prior implanted coronary drug eluting stent restenosisIntravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management. | Procedure or surgery | Emperor paclitaxel coated balloon, Magic Touch sirolimus coated balloon, Xience chromium-cobalt everolimus eluting stent |
Primary outcome
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
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.
Occurrence of target lesion revascularization
Time frame: 6 months
The need for further revascularization of the target lesion after treatment with either study device.
7 secondary outcomes
Percentage late lumen loss
Time frame: 6 months
Percentage intraluminal gain after treatment
Time frame: index procedure
Square millimetre intraluminal gain after treatment
Time frame: index procedure
Percentage intraluminal gain after treatment
Time frame: 6 months
Square millimeter intraluminal gain after treatment
Time frame: 6 months
Endothelium coverage in micrometers
Time frame: 6 months
Late lumen loss in square millimetres
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 35694680Kulyassa 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.
- Derived from this study: PubMed 39997337Kulyassa 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.
- Link to design and feasibility manuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
István F Édes, MD PhD principal investigator
Semmelweis University Heart and Vascular Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular management of prior implanted coronary drug eluting stent restenosis in people with Coronary Stent Restenosis, run by Semmelweis University Heart and Vascular Center at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of new onset target vessel myocardial infarction (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862052, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.