Treatment of In-Stent Restenosis 2 Study

Summary

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).

Timeline

Start

2018-10-01

Primary completion

2021-11-30

Completion

2021-12-31

Outcome

Missed primary endpoint

paper The noninferiority of SEB compared with PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not demonstrated PMID 40171676 ↗

Publications

• 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.

Drugs

Indications