Treatment of Coronary In-Stent Restenosis

Study Overview
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Brief Summary
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The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus.

Detailed Description
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In-stent restenosis after coronary angioplasty is currently one of the main limitations of this method, leading to a recurrence of exertional angina pectoris or manifesting as acute coronary syndrome. Histopathologic substrate of in-stent restenosis is neointimal hyperplasia. Repeated plain balloon angioplasty or using cutting balloon catheters in the treatment of in-stent restenosis does not achieve satisfactory results. Brachytherapy, used in the past, it has also abandoned. The current treatment of in-stent restenosis is the use of drug eluting stents. Local drug released from these stents prevents new neointimal hyperplasia.This treatment carries the risk of late thrombosis (due to delayed neoendotelization) the stent struts and requires rigorous long-term dual antiplatelet therapy with the risk of bleeding complications. The drug-coated balloon catheters provide short-term penetration of the active substance into the vascular wall, leading to the inhibition of hyperproliferation vascular smooth muscle cells, but due to short-term effect they do not affect negatively stent struts neoendotelization. Comparable effects of in-stent restenosis therapy using paclitaxel releasing balloons was demonstrated in comparison with paclitaxel releasing stents, however, the development of drug eluting stents meanwhile progressed. The aim of our study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus. Primary endpoint of our study is late lumen loss, because it represents accurate angiographic parameter predicting the need for repeat revascularisation and thus the clinical benefit for the patient. The 3rd observational, non-randomised arm compares the treatment with seal-wing paclitaxel-eluting balloon with two randomised arms (PEB vs. EES). 3-year long term clinical follow-up of iopromide-coated PEB and EES arms was performed. All clinical MACE (CV death, AMI and TVR) were recorded. Subanalysis of seal-wing PEB arm comparrng the treatment of BMS and DES-ISR was added.

Official Title
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Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Drug Eluting Paclitaxel-coated Balloon and Drug Eluting Stent With Everolimus.

Conditions
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Restenosis

Intervention / Treatment
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* Device: paclitaxel-coated balloon catheter with Iopromide coating
* Device: drug eluting stent with everolimus
* Device: seal-wing paclitaxel-eluting balloon catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of percutaneous coronary intervention with stent placement verified coronary in-stent restenosis suitable for percutaneous re-intervention signed informed consent Exclusion Criteria: contraindication to long term dual antiplatelet therapy increased risk of bleeding known generalized malignancy pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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
Interventional Model Description: iopromide coated paclitaxel-eluting balloon catheter
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iopromide paclitaxel-eluting balloon<br>Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter (iopomide coating) | Device: paclitaxel-coated balloon catheter with Iopromide coating<br>* Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter<br>* Other names: Sequent Please;|
| Active Comparator: drug eluting stent<br>Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus | Device: drug eluting stent with everolimus<br>* Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus<br>* Other names: Promus;|
| Other: seal-wing PEB<br>Observational, non-randomised arm: Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter | Device: seal-wing paclitaxel-eluting balloon catheter<br>* Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter<br>* Other names: Protege;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss | Late loss was defined as the minimal vessel lumen diameter immediately after the procedure minus the lumen diameter at angiographic follow-up | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events | Major Adverse Cardiac Events are defined as cardiovascular death, acute myocardial infarction or target vessel revascularisation | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, stent, restenosis