Treatment of In-Stent Restenosis 2 Study

Coronary Restenosis Clinical Trial

— TIS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667313
• Other study ID #: FNO-TIS 2
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Combination Product:
• sirolimus-eluting balloon (SEB) MagicTouch
Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon
• paclitaxel-eluting balloon (PEB) Sequent Please
Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon

Locations

Country	Name	City	State
Czechia	Cardiovascular Department of University Hospital	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumem loss (LLL)	the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD	12-month
Secondary	repeated binary restenosis	recurrence of stenosis =50%	12-month
Secondary	major adverse cardiac events (MACE)	cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR]	12-month