Treatment of Coronary In-Stent Restenosis

Not Applicable

Completed

• Conditions: Restenosis
• Interventions: Device: paclitaxel-coated balloon catheter with Iopromide coating; Device: drug eluting stent with everolimus; Device: seal-wing paclitaxel-eluting balloon catheter

• Registration Number: NCT01735825
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-28
• Primary Completion: 2015-07
• Study Completion: 2018-06
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iopromide paclitaxel-eluting balloon	paclitaxel-coated balloon catheter with Iopromide coating	Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter (iopomide coating)
drug eluting stent	drug eluting stent with everolimus	Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
seal-wing PEB	seal-wing paclitaxel-eluting balloon catheter	Observational, non-randomised arm: Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter

Primary Outcome Measures

Name	Time	Method
Late lumen loss	12 month	Late loss was defined as the minimal vessel lumen diameter immediately after the procedure minus the lumen diameter at angiographic follow-up

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	12 month	Major Adverse Cardiac Events are defined as cardiovascular death, acute myocardial infarction or target vessel revascularisation

Trial Locations

Locations (1)

University Hospital; 🇨🇿 Ostrava, Czechia