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NCT04862052: OPEN-ISR
Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis
NA trial testing Intravascular management of prior implanted coronary drug eluting stent restenosis in Coronary Stent Restenosis in 150 participants. Currently enrolling.
1 January 2025
Quick facts
| Lead sponsor | Semmelweis University Heart and Vascular Center |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 26 April 2021 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2025 |
| Sites | 2 locations across Hungary |
Drugs / interventions tested
- Intravascular management of prior implanted coronary drug eluting stent restenosis
Conditions studied
- Coronary Stent Restenosis — all drugs for Coronary Stent Restenosis →
Sponsor
Semmelweis University Heart and Vascular Center
Who can join
Adults 18 to 85, any sex, with Coronary Stent Restenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Design and Feasibility of Optimal Treatment for Coronary Drug-Eluting Stent In-Stent Restenosis (OPEN-ISR)-A Prospective, Randomised, Multicentre Clinical Trial.
Kulyassa PM, Németh BT, Hizoh I, Jankó LK, et al · · 2025 · cited 3× · PMID 39997337 · DOI 10.3390/jpm15020060 -
Recent Advances in the Treatment of Coronary In-Stent Restenosis.
Sartore L, Gitto M, Oliva A, Kakizaki R, et al · · 2024 · cited 3× · PMID 39742224 · DOI 10.31083/j.rcm2512433 -
Coronary drug-coated balloons: Current evidence and emerging trends.
Bhandari M, Pradhan A, Behera S, Singh AK. · · 2025 · PMID 41479994 · DOI 10.4330/wjc.v17.i12.111468
Verify or expand the search:
- PubMed search for NCT04862052
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Semmelweis University Heart and Vascular Center trials
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- NCT06173089 — REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04862052 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Semmelweis University Heart and Vascular Center
- Last refreshed: 22 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04862052.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing