Overview

This trial is active, not recruiting.

Condition restenosis
Treatments paclitaxel-coated balloon catheter with iopromide coating, drug eluting stent with everolimus, seal-wing paclitaxel-eluting balloon catheter
Phase phase 4
Sponsor University Hospital Ostrava
Start date January 2012
End date July 2015
Trial size 120 participants
Trial identifier NCT01735825, FNO-KVO 631/2011 Pleva

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter (iopomide coating)
paclitaxel-coated balloon catheter with iopromide coating Sequent Please
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter
(Active Comparator)
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
drug eluting stent with everolimus Promus
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
(Other)
Observational, non-randomised arm: Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter
seal-wing paclitaxel-eluting balloon catheter Protege
Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter

Primary Outcomes

Measure
Late lumen loss
time frame: 12 month

Secondary Outcomes

Measure
Major Adverse Cardiac Events
time frame: 12 month

Eligibility Criteria

Male or female participants from 20 years up to 90 years old.

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

Additional Information

Official title Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Drug Eluting Paclitaxel-coated Balloon and Drug Eluting Stent With Everolimus.
Principal investigator Leos Pleva, M.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Hospital Ostrava.