Last reviewed · How we verify
NCT03667313: TIS2
Treatment of In-Stent Restenosis 2 Study
Phase 3 trial testing sirolimus-eluting balloon (SEB) MagicTouch in Coronary Restenosis in 200 participants. Completed in 31 December 2021.
30 November 2021
Quick facts
| Lead sponsor | University Hospital Ostrava |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 October 2018 |
| Primary completion | 30 November 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- sirolimus-eluting balloon (SEB) MagicTouch
- paclitaxel-eluting balloon (PEB) Sequent Please
Conditions studied
- Coronary Restenosis — all drugs for Coronary Restenosis →
Sponsor
University Hospital Ostrava
Who can join
18 and older, any sex, with Coronary Restenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Intrastent Restenosis: A Comprehensive Review.
Bajeu IT, Niculescu AG, Scafa-Udriște A, Andronescu E. · · 2024 · cited 18× · PMID 38338993 · DOI 10.3390/ijms25031715 -
Comparing the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: A Prospective Randomized Study (TIS 2 Study).
Pleva L, Kukla P, Kovarnik T, Zapletalova J. · · 2025 · cited 4× · PMID 40171676 · DOI 10.1161/circinterventions.124.014677
Verify or expand the search:
- PubMed search for NCT03667313
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Coronary Restenosis
Currently open trials in the same condition.
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Other University Hospital Ostrava trials
Trials by the same sponsor.
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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 NCT03667313 (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 University Hospital Ostrava
- Last refreshed: 7 December 2022
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/NCT03667313.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing