Treatment of In-Stent Restenosis 2 Study (TIS2)

University Hospital Ostrava

Status and phase

Completed

Phase 3

Conditions

Coronary Restenosis

Treatments

Combination Product: sirolimus-eluting balloon (SEB) MagicTouch

Combination Product: paclitaxel-eluting balloon (PEB) Sequent Please

Study type

Interventional

Funder types

Other

Identifiers

NCT03667313

FNO-TIS 2

Details and patient eligibility

About

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).

Full description

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]).

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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