Treatment of In-Stent Restenosis 2 Study (TIS2)

December 6, 2022 updated by: University Hospital Ostrava

Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters

The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current therapy for in-stent restenosis (ISR) is based on the drug-eluting stents (DES) or drug-eluting balloon catheters (DEB). In clinical practice, paclitaxel is used as an effective antiproliferative agent loaded into DEB (paclitaxel-eluting balloon catheters; PEB).

In contrast to paclitaxel, sirolimus is difficult to deliver on the balloon surface, due to insufficient tissue uptake and shorter tissue retention of limus drugs. It was found that phospholipid-encapsulated sirolimus nanoparticles could be used for coating balloon catheters to provide efficient drug transfer to vessel wall with high tissue concentration.

This prospective randomized non-inferiority study compares the efficacy of new sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).

The primary end-point is in-segment late lumen loss (LLL) at 12 months as measured by quantitative coronary angiography (QCA).

Secondary end-points are the incidence of binary ISR (˃50% DS) and the overall incidence of 12-month major adverse cardiac events (MACE; cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR]).

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

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, 70852
        • Cardiovascular Department of 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with BMS- or DES-ISR (˃50% diameter stenosis; DS)
  • ≥18 years of age
  • willing to sign an Informed consent

Exclusion Criteria:

  • concomitant diseases with an expected survival time of less than 12 months
  • or that limited the possibility of control coronary aniography (e.g., advanced renal failure).
  • impossibility of long-term (6 months) dual antiplatelet treatment

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sirolimus-eluting balloon (SEB)
treatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB
Combination product: sirolimus-eluting balloon (SEB) MagicTouch
Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon
Other Names:
  • MagicTouch
Active Comparator: paclitaxel-eluting balloon (PEB)
treatment of BMS- or DES-ISR with PEB
Combination product: paclitaxel-eluting balloon (PEB) Sequent Please
Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon
Other Names:
  • Sequent Please

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late lumem loss (LLL)
Time Frame: 12-month
the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD
12-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
repeated binary restenosis
Time Frame: 12-month
recurrence of stenosis ≥50%
12-month
major adverse cardiac events (MACE)
Time Frame: 12-month
cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR]
12-month

Collaborators and Investigators

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

Sponsor

University Hospital Ostrava

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)

October 1, 2018

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Estimate)

December 7, 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-TIS 2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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