RestenosisTISNCT01735825
Treatment of Coronary In-Stent Restenosis
A study testing paclitaxel-coated balloon catheter with Iopromide coating, drug eluting stent with everolimus and seal-wing paclitaxel-eluting balloon catheter in people with Restenosis, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Restenosis
- What is being tested?
- paclitaxel-coated balloon catheter with Iopromide coating, drug eluting stent with everolimus and seal-wing paclitaxel-eluting balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2012to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of percutaneous coronary intervention with stent placement
- verified coronary in-stent restenosis suitable for percutaneous re-intervention
- signed informed consent
Who cannot join
- contraindication to long term dual antiplatelet therapy
- increased risk of bleeding
- known generalized malignancy
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Drug Eluting Paclitaxel-coated Balloon and Drug Eluting Stent With Everolimus.
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.
Read the detailed description
In-stent restenosis after coronary angioplasty is currently one of the main limitations of this method, leading to a recurrence of exertional angina pectoris or manifesting as acute coronary syndrome. Histopathologic substrate of in-stent restenosis is neointimal hyperplasia.
Repeated plain balloon angioplasty or using cutting balloon catheters in the treatment of in-stent restenosis does not achieve satisfactory results. Brachytherapy, used in the past, it has also abandoned. The current treatment of in-stent restenosis is the use of drug eluting stents. Local drug released from these stents prevents new neointimal hyperplasia.This treatment carries the risk of late thrombosis (due to delayed neoendotelization) the stent struts and requires rigorous long-term dual antiplatelet therapy with the risk of bleeding complications. The drug-coated balloon catheters provide short-term penetration of the active substance into the vascular wall, leading to the inhibition of hyperproliferation vascular smooth muscle cells, but due to short-term effect they do not affect negatively stent struts neoendotelization. Comparable effects of in-stent restenosis therapy using paclitaxel releasing balloons was demonstrated in comparison with paclitaxel releasing stents, however, the development of drug eluting stents meanwhile progressed. The aim of our 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. Primary endpoint of our study is late lumen loss, because it represents accurate angiographic parameter predicting the need for repeat revascularisation and thus the clinical benefit for the patient.
The 3rd observational, non-randomised arm compares the treatment with seal-wing paclitaxel-eluting balloon with two randomised arms (PEB vs. EES).
3-year long term clinical follow-up of iopromide-coated PEB and EES arms was performed. All clinical MACE (CV death, AMI and TVR) were recorded.
Subanalysis of seal-wing PEB arm comparrng the treatment of BMS and DES-ISR was added.
- Conditions
- Restenosis
- Being tested
- paclitaxel-coated balloon catheter with Iopromide coating, drug eluting stent with everolimus, seal-wing paclitaxel-eluting balloon catheter
- Keywords
- coronary artery disease, stent, restenosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel-coated balloon catheter with Iopromide coatingDevice
Also called Sequent Please
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter
drug eluting stent with everolimusDevice
Also called Promus
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
seal-wing paclitaxel-eluting balloon catheterDevice
Also called Protege
Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter
| Study group | Role | What they receive |
|---|---|---|
| iopromide paclitaxel-eluting balloon | Experimental | Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter (iopomide coating) Receives: Device: paclitaxel-coated balloon catheter with Iopromide coating |
| drug eluting stent | Active comparator | Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus Receives: Device: drug eluting stent with everolimus |
| seal-wing PEB | Other | Observational, non-randomised arm:
Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter Receives: Device: seal-wing paclitaxel-eluting balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Secondary outcomes (1)
Major Adverse Cardiac Events
Major Adverse Cardiac Events are defined as cardiovascular death, acute myocardial infarction or target vessel revascularisation
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2015
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RestenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- iopromide coated paclitaxel-eluting balloon catheter
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leos Pleva, M.D., Principal investigator, Cardiovascular Department, University Hospital Ostrava, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735825
- Sponsor's protocol ID
- FNO-KVO 631/2011 Pleva
- Acronym
- TIS
- Status last verified
- Dec 2022
- First submitted
- 7 Nov 2012
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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
Pleva 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.
PubMed 30019843Pleva 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.
PubMed 28651572Pleva 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.
PubMed 27069104
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Drug Eluting Paclitaxel-coated Balloon and Drug Eluting Stent With Everolimus.
- ClinicalTrials.gov ID
- NCT01735825
- Acronym / sponsor ID
- TIS / FNO-KVO 631/2011 Pleva
- Conditions
- Restenosis
- Keywords
- coronary artery disease, stent, restenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In-stent restenosis after coronary angioplasty is currently one of the main limitations of this method, leading to a recurrence of exertional angina pectoris or manifesting as acute coronary syndrome. Histopathologic substrate of in-stent restenosis is neointimal hyperplasia.
Repeated plain balloon angioplasty or using cutting balloon catheters in the treatment of in-stent restenosis does not achieve satisfactory results. Brachytherapy, used in the past, it has also abandoned. The current treatment of in-stent restenosis is the use of drug eluting stents. Local drug released from these stents prevents new neointimal hyperplasia.This treatment carries the risk of late thrombosis (due to delayed neoendotelization) the stent struts and requires rigorous long-term dual antiplatelet therapy with the risk of bleeding complications. The drug-coated balloon catheters provide short-term penetration of the active substance into the vascular wall, leading to the inhibition of hyperproliferation vascular smooth muscle cells, but due to short-term effect they do not affect negatively stent struts neoendotelization. Comparable effects of in-stent restenosis therapy using paclitaxel releasing balloons was demonstrated in comparison with paclitaxel releasing stents, however, the development of drug eluting stents meanwhile progressed. The aim of our 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. Primary endpoint of our study is late lumen loss, because it represents accurate angiographic parameter predicting the need for repeat revascularisation and thus the clinical benefit for the patient.
The 3rd observational, non-randomised arm compares the treatment with seal-wing paclitaxel-eluting balloon with two randomised arms (PEB vs. EES).
3-year long term clinical follow-up of iopromide-coated PEB and EES arms was performed. All clinical MACE (CV death, AMI and TVR) were recorded.
Subanalysis of seal-wing PEB arm comparrng the treatment of BMS and DES-ISR was added.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- iopromide coated paclitaxel-eluting balloon catheter
| Arm | Type | Receives |
|---|---|---|
| iopromide paclitaxel-eluting balloon | Experimental | Device: paclitaxel-coated balloon catheter with Iopromide coatingPatients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter (iopomide coating) |
| drug eluting stent | Active comparator | Device: drug eluting stent with everolimusPatients with coronary in-stent restenosis treated by drug eluting stent with everolimus |
| seal-wing PEB | Other | Device: seal-wing paclitaxel-eluting balloon catheterObservational, non-randomised arm: Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- history of percutaneous coronary intervention with stent placement
- verified coronary in-stent restenosis suitable for percutaneous re-intervention
- signed informed consent
Key exclusion criteria (4 listed)
- contraindication to long term dual antiplatelet therapy
- increased risk of bleeding
- known generalized malignancy
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxel-coated balloon catheter with Iopromide coatingAlso: Sequent PleasePatients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter | Device | iopromide paclitaxel-eluting balloon |
| drug eluting stent with everolimusAlso: PromusPatients with coronary in-stent restenosis treated by drug eluting stent with everolimus | Device | drug eluting stent |
| seal-wing paclitaxel-eluting balloon catheterAlso: ProtegePatients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter | Device | seal-wing PEB |
Primary outcome
Late lumen loss
Time frame: 12 month
Late loss was defined as the minimal vessel lumen diameter immediately after the procedure minus the lumen diameter at angiographic follow-up
1 secondary outcome
Major Adverse Cardiac Events
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Background1.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
- Derived from this study: PubMed 30019843Pleva 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.
- Derived from this study: PubMed 28651572Pleva 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.
- Derived from this study: PubMed 27069104Pleva 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.
Related trials for Restenosis
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
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A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leos Pleva, M.D. principal investigator
Cardiovascular Department, University Hospital Ostrava, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paclitaxel-coated balloon catheter with Iopromide coating, drug eluting stent with everolimus and seal-wing paclitaxel-eluting balloon catheter in people with Restenosis, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late lumen loss (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01735825, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.