Treatment of In-Stent Restenosis 2 Study

Phase 3

Completed

• Conditions: Coronary Restenosis
• Interventions: Combination Product: paclitaxel-eluting balloon (PEB) Sequent Please; Combination Product: sirolimus-eluting balloon (SEB) MagicTouch

• Registration Number: NCT03667313
• Lead Sponsor: University Hospital Ostrava

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 \[TVR\]).

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Study Start: 2018-10-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paclitaxel-eluting balloon (PEB)	paclitaxel-eluting balloon (PEB) Sequent Please	treatment of BMS- or DES-ISR with PEB
sirolimus-eluting balloon (SEB)	sirolimus-eluting balloon (SEB) MagicTouch	treatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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%

Trial Locations

Locations (1)

Cardiovascular Department of University Hospital; 🇨🇿 Ostrava, Czechia