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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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2018-10-01
2021-12-31
Brief Summary
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Detailed Description
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In contrast to paclitaxel, sirolimus is difficult to deliver on the balloon surface, due to insufficient tissue uptake and shorter tissue retention of limus drugs. It was found that phospholipid-encapsulated sirolimus nanoparticles could be used for coating balloon catheters to provide efficient drug transfer to vessel wall with high tissue concentration.
This prospective randomized non-inferiority study compares the efficacy of new 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).
The primary end-point is in-segment late lumen loss (LLL) at 12 months as measured by quantitative coronary angiography (QCA).
Secondary end-points are the incidence of binary ISR (˃50% DS) and the overall incidence of 12-month major adverse cardiac events (MACE; cardiovascular death, non-fatal acute myocardial infarction \[AIM\], or target vessel revascularization \[TVR\]).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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sirolimus-eluting balloon (SEB)
treatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB
sirolimus-eluting balloon (SEB) MagicTouch
Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon
paclitaxel-eluting balloon (PEB)
treatment of BMS- or DES-ISR with PEB
paclitaxel-eluting balloon (PEB) Sequent Please
Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon
Interventions
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sirolimus-eluting balloon (SEB) MagicTouch
Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon
paclitaxel-eluting balloon (PEB) Sequent Please
Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥18 years of age
* willing to sign an Informed consent
Exclusion Criteria
* or that limited the possibility of control coronary aniography (e.g., advanced renal failure).
* impossibility of long-term (6 months) dual antiplatelet treatment
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Locations
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Cardiovascular Department of University Hospital
Ostrava, , Czechia
Countries
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References
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Pleva L, Kukla P, Kovarnik T, Zapletalova J. 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). Circ Cardiovasc Interv. 2025 May;18(5):e014677. doi: 10.1161/CIRCINTERVENTIONS.124.014677. Epub 2025 Apr 2.
Other Identifiers
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FNO-TIS 2
Identifier Type: -
Identifier Source: org_study_id
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