Treatment of Coronary In-Stent Restenosis
TIS
Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Drug Eluting Paclitaxel-coated Balloon and Drug Eluting Stent With Everolimus.
1 other identifier
interventional
199
1 country
1
Brief Summary
The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 7, 2012
CompletedFirst Posted
Study publicly available on registry
November 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedDecember 8, 2022
December 1, 2022
3.5 years
November 7, 2012
December 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Late lumen loss
Late loss was defined as the minimal vessel lumen diameter immediately after the procedure minus the lumen diameter at angiographic follow-up
12 month
Secondary Outcomes (1)
Major Adverse Cardiac Events
12 month
Other Outcomes (1)
Binary restenosis
12 month
Study Arms (3)
iopromide paclitaxel-eluting balloon
EXPERIMENTALPatients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter (iopomide coating)
drug eluting stent
ACTIVE COMPARATORPatients with coronary in-stent restenosis treated by drug eluting stent with everolimus
seal-wing PEB
OTHERObservational, non-randomised arm: Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter
Interventions
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter
Eligibility Criteria
You may qualify if:
- history of percutaneous coronary intervention with stent placement
- verified coronary in-stent restenosis suitable for percutaneous re-intervention
- signed informed consent
You may not qualify if:
- contraindication to long term dual antiplatelet therapy
- increased risk of bleeding
- known generalized malignancy
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Ostrava, 708 52, Czechia
Related Publications (4)
1.TAXUS III Trial: In-Stent Restenosis Treated With Stent-Based Delivery of Paclitaxel Incorporated in a Slow-Release Polymer Formulation J. van der Giessen, Circulation 2003,107:559-564: 2.Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. Kastrati A,JAMA 2005;293:165-71 3.Treatment of coronary in-stent restenosis with a paclitaxel-coated ballon catheter, B.Scheller, NEJM,355;20,Nov 16,2006 4.Randomized Trial of Paclitaxel- Versus Sirolimus-Eluting Stents for Treatment of Coronary Restenosis in Sirolimus-Eluting Stents The ISAR-DESIRE 2 Study. Mehilli J, J Am Coll Cardiol 2010 Mar 5 5.Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. Stone GW,. N Engl J Med 2010 May 6;362:1663-74 6.Angiogaphic surrogate end points in drug-eluting stent trials, S.J.Pocock, JACC, Vol 51,No 1,2008
BACKGROUNDPleva L, Kukla P, Zapletalova J, Hlinomaz O. Long-term outcomes after treatment of bare-metal stent restenosis with paclitaxel-coated balloon catheters or everolimus-eluting stents: 3-year follow-up of the TIS clinical study. Catheter Cardiovasc Interv. 2018 Nov 15;92(6):E416-E424. doi: 10.1002/ccd.27688. Epub 2018 Jul 18.
PMID: 30019843DERIVEDPleva L, Kukla P, Zapletalova J, Hlinomaz O. Efficacy of a seal-wing paclitaxel-eluting balloon catheters in the treatment of bare metal stent restenosis. BMC Cardiovasc Disord. 2017 Jun 26;17(1):168. doi: 10.1186/s12872-017-0602-6.
PMID: 28651572DERIVEDPleva L, Kukla P, Kusnierova P, Zapletalova J, Hlinomaz O. Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis: The Treatment of In-Stent Restenosis Study. Circ Cardiovasc Interv. 2016 Apr;9(4):e003316. doi: 10.1161/CIRCINTERVENTIONS.115.003316.
PMID: 27069104DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leos Pleva, M.D.
Cardiovascular Department, University Hospital Ostrava, Czech Republic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2012
First Posted
November 28, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2015
Study Completion
June 1, 2018
Last Updated
December 8, 2022
Record last verified: 2022-12