Treatment of In-Stent Restenosis 2 Study

University Hospital Ostrava200 enrolled

Overview

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).

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 \[TVR\]).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Coronary Restenosis

Interventions

sirolimus-eluting balloon (SEB) MagicTouchCOMBINATION_PRODUCT

Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon

paclitaxel-eluting balloon (PEB) Sequent PleaseCOMBINATION_PRODUCT

Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiovascular Department of University Hospital

Ostrava, Czechia

Outcomes

Primary Outcomes

Late lumem loss (LLL)

the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD

Time frame: 12-month

Secondary Outcomes

repeated binary restenosis

recurrence of stenosis ≥50%

Time frame: 12-month

major adverse cardiac events (MACE)

cardiovascular death, non-fatal acute myocardial infarction \[AIM\], or target vessel revascularization \[TVR\]

Time frame: 12-month

Data from ClinicalTrials.gov

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