Treatment of In-Stent Restenosis 2 Study

Current therapy for in-stent restenosis (ISR) is based on the drug-eluting stents (DES) or drug-eluting balloon catheters (DEB). In clinical practice, paclitaxel is used as an effective antiproliferative agent loaded into DEB (paclitaxel-eluting balloon catheters; PEB).

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]).

Inclusion criteria

• patients with BMS- or DES-ISR (˃50% diameter stenosis; DS)
• ≥18 years of age
• willing to sign an Informed consent

Exclusion criteria

• concomitant diseases with an expected survival time of less than 12 months
• or that limited the possibility of control coronary aniography (e.g., advanced renal failure).
• impossibility of long-term (6 months) dual antiplatelet treatment