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TIS2: Treatment of In-Stent Restenosis 2 Study

Sponsor
University Hospital Ostrava (Other)
Overall Status
Recruiting
CT.gov ID
NCT03667313
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
39
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Combination Product: sirolimus-eluting balloon (SEB) MagicTouch
  • Combination Product: paclitaxel-eluting balloon (PEB) Sequent Please
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Late lumem loss (LLL) [12-month]

      the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD

    Secondary Outcome Measures

    1. repeated binary restenosis [12-month]

      recurrence of stenosis ≥50%

    2. major adverse cardiac events (MACE) [12-month]

      cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiovascular Department of University Hospital Ostrava Czechia 70852

    Sponsors and Collaborators

    • University Hospital Ostrava

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Ostrava
    ClinicalTrials.gov Identifier:
    NCT03667313
    Other Study ID Numbers:
    • FNO-TIS 2
    First Posted:
    Sep 12, 2018
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital Ostrava
    in-stent restenosis; sirolimus-; paclitaxel-eluting balloon
    Additional relevant MeSH terms:
    Coronary Restenosis
    Sirolimus
    Paclitaxel

    Study Results

    No Results Posted as of Feb 17, 2021