Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis
NCT ID: NCT04862052
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2021-04-26
2025-01-01
Brief Summary
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These are the:
* Magic Touch - sirolimus coated balloon
* Emperor - paclitaxel and dextran coated balloon
* Xience - chromium-cobalt everolimus eluting stent
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Xience chromium-cobalt everolimus eluting stent
The Xience chromium-cobalt everolimus eluting stent will be evaluated in prior implanted coronary drug eluting stent restenosis.
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.
Emperor paclitaxel coated balloon
The Emperor paclitaxel coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.
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.
Magic Touch sirolimus coated balloon
The Magic Touch sirolimus coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or nursing
18 Years
85 Years
ALL
No
Sponsors
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Semmelweis University Heart and Vascular Center
OTHER
Responsible Party
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Istvan Edes
Associate Professor
Principal Investigators
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István F Édes, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University Heart and Vascular Center
Locations
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Semmelweis University Heart and Vascular Center
Budapest, Budapest, Hungary
University of Szeged, Department of Invasive Cardiology
Szeged, Csongád-Csanád, Hungary
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Link to design and feasibility manuscript
Other Identifiers
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OPEN ISR - 001
Identifier Type: -
Identifier Source: org_study_id
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