Coronary RestenosisPhase 3TIS2NCT03667313
Treatment of In-Stent Restenosis 2 Study
A Phase 3 study testing sirolimus-eluting balloon (SEB) MagicTouch and paclitaxel-eluting balloon (PEB) Sequent Please in people with Coronary Restenosis, run by University Hospital Ostrava at 1 site in Czechia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Restenosis
- What is being tested?
- sirolimus-eluting balloon (SEB) MagicTouch and paclitaxel-eluting balloon (PEB) Sequent Please
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2018to 31 Dec 2021
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with BMS- or DES-ISR (˃50% diameter stenosis; DS)
- ≥18 years of age
- willing to sign an Informed consent
Who cannot join
- 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
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 Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters
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).
Read the 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]).
- Conditions
- Coronary Restenosis
- Being tested
- sirolimus-eluting balloon (SEB) MagicTouch, paclitaxel-eluting balloon (PEB) Sequent Please
- Keywords
- in-stent restenosis; sirolimus-; paclitaxel-eluting balloon
- Medical subject headings
- Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimus-eluting balloon (SEB) MagicTouchCombination product
Also called MagicTouch
Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon
paclitaxel-eluting balloon (PEB) Sequent PleaseCombination product
Also called Sequent Please
Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon
| Study group | Role | What they receive |
|---|---|---|
| sirolimus-eluting balloon (SEB) | Experimental | treatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB Receives: Combination Product: sirolimus-eluting balloon (SEB) MagicTouch |
| paclitaxel-eluting balloon (PEB) | Active comparator | treatment of BMS- or DES-ISR with PEB Receives: Combination Product: paclitaxel-eluting balloon (PEB) Sequent Please |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumem loss (LLL)
the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD
Measured: 12-month
Secondary outcomes (2)
repeated binary restenosis
recurrence of stenosis ≥50%
Measured: 12-month
major adverse cardiac events (MACE)
cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR]
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 posted12 Sep 2018
- Study start1 Oct 2018
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667313
- Sponsor's protocol ID
- FNO-TIS 2
- Acronym
- TIS2
- Status last verified
- Dec 2022
- First submitted
- 10 Sep 2018
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40171676
Study at a glance
From the registry record, last updated by the sponsor on 7 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 Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters
- ClinicalTrials.gov ID
- NCT03667313
- Acronym / sponsor ID
- TIS2 / FNO-TIS 2
- Conditions
- Coronary Restenosis
- Keywords
- in-stent restenosis; sirolimus-; paclitaxel-eluting balloon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Sep 2018 (actual)
- 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 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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sirolimus-eluting balloon (SEB) | Experimental | Combination Product: sirolimus-eluting balloon (SEB) MagicTouchtreatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB |
| paclitaxel-eluting balloon (PEB) | Active comparator | Combination Product: paclitaxel-eluting balloon (PEB) Sequent Pleasetreatment of BMS- or DES-ISR with PEB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with BMS- or DES-ISR (˃50% diameter stenosis; DS)
- ≥18 years of age
- willing to sign an Informed consent
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| sirolimus-eluting balloon (SEB) MagicTouchAlso: MagicTouchPatients with coronary in-stent restenosis treated with sirolimus-eluting balloon | Combination product | sirolimus-eluting balloon (SEB) |
| paclitaxel-eluting balloon (PEB) Sequent PleaseAlso: Sequent PleasePatients with coronary in-stent restenosis treated with paclitaxel-eluting balloon | Combination product | paclitaxel-eluting balloon (PEB) |
Primary outcome
Late lumem loss (LLL)
Time frame: 12-month
the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD
2 secondary outcomes
repeated binary restenosis
Time frame: 12-month
major adverse cardiac events (MACE)
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 7 Dec 2022.
- Derived from this study: PubMed 40171676Pleva 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sirolimus-eluting balloon (SEB) MagicTouch and paclitaxel-eluting balloon (PEB) Sequent Please in people with Coronary 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 3 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 7 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 lumem loss (LLL) (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 NCT03667313, which also lists 1 linked publication.
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 7 Dec 2022.