Treatment of In-Stent Restenosis 2 Study

Study Overview
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Brief Summary
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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
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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]).

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

Conditions
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Coronary Restenosis

Intervention / Treatment
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* Combination Product: sirolimus-eluting balloon (SEB) MagicTouch
* Combination Product: paclitaxel-eluting balloon (PEB) Sequent Please


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sirolimus-eluting balloon (SEB)<br>treatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB | Combination Product: sirolimus-eluting balloon (SEB) MagicTouch<br>* Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon<br>* Other names: MagicTouch;|
| Active Comparator: paclitaxel-eluting balloon (PEB)<br>treatment of BMS- or DES-ISR with PEB | Combination Product: paclitaxel-eluting balloon (PEB) Sequent Please<br>* Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon<br>* Other names: Sequent Please;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in-stent restenosis; sirolimus-; paclitaxel-eluting balloon