Treatment of Coronary In-Stent Restenosis (TIS)

University Hospital Ostrava

Status: Completed

Conditions: Restenosis

Treatments: Device: drug eluting stent with everolimus; Device: paclitaxel-coated balloon catheter with Iopromide coating; Device: seal-wing paclitaxel-eluting balloon catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01735825

FNO-KVO 631/2011 Pleva

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 199 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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199 participants in 3 patient groups

iopromide paclitaxel-eluting balloon

Experimental group

Description:

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

Treatment:

Device: paclitaxel-coated balloon catheter with Iopromide coating

drug eluting stent

Active Comparator group

Description:

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

Treatment:

Device: drug eluting stent with everolimus

seal-wing PEB

Other group

Description:

Observational, non-randomised arm: Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter

Treatment:

Device: seal-wing paclitaxel-eluting balloon catheter