Treatment of In-Stent Restenosis 2 Study

Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03667313

Acronym

TIS2

Enrollment

200

Registered

2018-09-12

Start date

2018-10-01

Completion date

2021-12-31

Last updated

2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Restenosis

Keywords

in-stent restenosis; sirolimus-; paclitaxel-eluting balloon

Brief 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).

Detailed 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 \[TVR\]).

Interventions

COMBINATION_PRODUCTsirolimus-eluting balloon (SEB) MagicTouch

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

COMBINATION_PRODUCTpaclitaxel-eluting balloon (PEB) Sequent Please

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Late lumem loss (LLL)	12-month	the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD

Secondary

Measure	Time frame	Description
major adverse cardiac events (MACE)	12-month	cardiovascular death, non-fatal acute myocardial infarction \[AIM\], or target vessel revascularization \[TVR\]
repeated binary restenosis	12-month	recurrence of stenosis ≥50%

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026