Treatment of In-Stent Restenosis 2 Study
TIS2
Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters
1 other identifier
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2018
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedDecember 7, 2022
December 1, 2022
3.2 years
September 10, 2018
December 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Late lumem loss (LLL)
the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD
12-month
Secondary Outcomes (2)
repeated binary restenosis
12-month
major adverse cardiac events (MACE)
12-month
Study Arms (2)
sirolimus-eluting balloon (SEB)
EXPERIMENTALtreatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB
paclitaxel-eluting balloon (PEB)
ACTIVE COMPARATORtreatment of BMS- or DES-ISR with PEB
Interventions
Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon
Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon
Eligibility Criteria
You may qualify if:
- patients with BMS- or DES-ISR (˃50% diameter stenosis; DS)
- ≥18 years of age
- willing to sign an Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Department of University Hospital
Ostrava, 70852, Czechia
Related Publications (1)
Pleva L, Kukla P, Kovarnik T, Zapletalova J. Comparing the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: A Prospective Randomized Study (TIS 2 Study). Circ Cardiovasc Interv. 2025 May;18(5):e014677. doi: 10.1161/CIRCINTERVENTIONS.124.014677. Epub 2025 Apr 2.
PMID: 40171676DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 12, 2018
Study Start
October 1, 2018
Primary Completion
November 30, 2021
Study Completion
December 31, 2021
Last Updated
December 7, 2022
Record last verified: 2022-12