Treatment of Coronary In-Stent Restenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2018-06-30

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.

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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.

Conditions

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Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

iopromide coated paclitaxel-eluting balloon catheter

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

double blind

Study Groups

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iopromide paclitaxel-eluting balloon

Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter (iopomide coating)

Group Type EXPERIMENTAL

paclitaxel-coated balloon catheter with Iopromide coating

Intervention Type DEVICE

Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter

drug eluting stent

Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus

Group Type ACTIVE_COMPARATOR

drug eluting stent with everolimus

Intervention Type DEVICE

Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus

seal-wing PEB

Observational, non-randomised arm:

Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter

Group Type OTHER

seal-wing paclitaxel-eluting balloon catheter

Intervention Type DEVICE

Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter

Interventions

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paclitaxel-coated balloon catheter with Iopromide coating

Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter

Intervention Type DEVICE

drug eluting stent with everolimus

Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus

Intervention Type DEVICE

seal-wing paclitaxel-eluting balloon catheter

Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter

Intervention Type DEVICE

Other Intervention Names

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Sequent Please Promus Protege

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