Treatment of Coronary In-Stent Restenosis (TIS)

December 6, 2022 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Ostrava, Czechia, 708 52
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iopromide paclitaxel-eluting balloon
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter (iopomide coating)
Device: paclitaxel-coated balloon catheter with Iopromide coating
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter
Other Names:
  • Sequent Please
Active Comparator: drug eluting stent
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
Device: drug eluting stent with everolimus
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
Other Names:
  • Promus
Other: seal-wing PEB

Observational, non-randomised arm:

Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter
Device: seal-wing paclitaxel-eluting balloon catheter
Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter
Other Names:
  • Protege

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binary restenosis
Time Frame: 12 month
Binary restenosis is defined as a > 50% diameter stenosis at angiographic follow-up.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Leos Pleva, M.D., Cardiovascular Department, University Hospital Ostrava, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-KVO 631/2011 Pleva

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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