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Treatment of In-Stent Restenosis 2 Study (TIS2)

Primary Purpose

Coronary Restenosis

Status
Completed
Phase
Phase 3
Locations
Czechia
Study Type
Interventional
Intervention
sirolimus-eluting balloon (SEB) MagicTouch
paclitaxel-eluting balloon (PEB) Sequent Please
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Restenosis focused on measuring in-stent restenosis; sirolimus-; paclitaxel-eluting balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Department of University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sirolimus-eluting balloon (SEB)

paclitaxel-eluting balloon (PEB)

Arm Description

treatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB

treatment of BMS- or DES-ISR with PEB

Outcomes

Primary Outcome Measures

Late lumem loss (LLL)
the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD

Secondary Outcome Measures

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

Full Information

First Posted
September 10, 2018
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT03667313
Brief Title
Treatment of In-Stent Restenosis 2 Study
Acronym
TIS2
Official Title
Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Restenosis
Keywords
in-stent restenosis; sirolimus-; paclitaxel-eluting balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sirolimus-eluting balloon (SEB)
Arm Type
Experimental
Arm Description
treatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB
Arm Title
paclitaxel-eluting balloon (PEB)
Arm Type
Active Comparator
Arm Description
treatment of BMS- or DES-ISR with PEB
Intervention Type
Combination Product
Intervention Name(s)
sirolimus-eluting balloon (SEB) MagicTouch
Other Intervention Name(s)
MagicTouch
Intervention Description
Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon
Intervention Type
Combination Product
Intervention Name(s)
paclitaxel-eluting balloon (PEB) Sequent Please
Other Intervention Name(s)
Sequent Please
Intervention Description
Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon
Primary Outcome Measure Information:
Title
Late lumem loss (LLL)
Description
the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD
Time Frame
12-month
Secondary Outcome Measure Information:
Title
repeated binary restenosis
Description
recurrence of stenosis ≥50%
Time Frame
12-month
Title
major adverse cardiac events (MACE)
Description
cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR]
Time Frame
12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cardiovascular Department of University Hospital
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia

12. IPD Sharing Statement

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Treatment of In-Stent Restenosis 2 Study

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