Chronic Coronary SyndromePhase 4TITAN-DEBNCT05674630
Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons
A Phase 4 study testing Magic Touch drug eluting balloon based strategy and Drug-eluting stent-based strategy in people with Chronic Coronary Syndrome, run by Cardiocentro Ticino at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- Magic Touch drug eluting balloon based strategy and Drug-eluting stent-based strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Feb 2023to 1 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI
- At least one significant de-novo coronary lesion (defined as diameter stenosis > 50% on angiography, with flow limiting features, confirmed with FFR ≤0.80 or iFR ≤0.89 and intended implantation of a long (≥30 mm) DES based on IVUS findings
- Written informed consent
Who cannot join
- Patients referred to the index procedure for an acute coronary syndrome
- Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery
- Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment
- Spontaneous coronary artery dissection (SCAD)
- Contraindications to adenosine administration (e.g. moderate to severe asthma or chronic obstructive pulmonary disease, heart rate <50 beats/min and systolic blood pressure <90 mmHg)
- Known pregnancy or breast-feeding patients
Show all 9Show fewer
- Life expectancy <1 year due to other severe non-cardiac disease
- Legally incompetent to provide informed consent
- Participation in another clinical study with an investigational product
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Enrico Frigoli, M.D. contact
Switzerland1 site, 1 recruiting
- Recruiting
Marco Valgimigli
Lugano, 6900
Enrico Frigoli, MD, +410918115111
About this study
Official title: TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons
The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions.
Participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.
Read the detailed description
Patients at coronary angiography who are deemed suitable for PCI are assessed for eligibility. Patients fulfilling all inclusion and no exclusion criteria can be consented for trial participation. After successful lesion preparation, defined as residual stenosis less than 30%, TIMI flow 3 and no major (type C) dissection of target lesion, consented patients will be randomized in a 1:1 ratio to a drug eluting balloon(DEB)-based or standard drug eluting stent(DES)-based strategy and further randomized in a 1:1 fashion, stratified based on DEB vs DES, to undergo invasive follow-up at 6 (±30 days) or 12 (±30 days) months.
- Conditions
- Chronic Coronary Syndrome
- Being tested
- Magic Touch drug eluting balloon based strategy, Drug-eluting stent-based strategy
- Keywords
- adult, chronic coronary syndrome, percutaneous intervention, significant de novo coronary lesion, FFR≤0.80, iFR≤0.89, long DES (≥30 mm), coronary lesion, drug eluting balloon, drug eluting stent, Magic Touch drug eluting balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magic Touch drug eluting balloon based strategyDevice
Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the experimental arm will receive treatment with drug eluting balloon (Magic Touch®) followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.
Drug-eluting stent-based strategyDevice
Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the control arm will receive treatment with drug-eluting stent followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.
| Study group | Role | What they receive |
|---|---|---|
| Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up | Experimental | Patients randomized to DEB-based strategy will receive treatment with DEB (Magic Touch, Concept Medical®) throughout the entire lesion length, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion. Receives: Device: Magic Touch drug eluting balloon based strategy |
| Drug eluting stent based strategy - 6/12 months invasive follow up | Active comparator | Percutaneous transluminal coronary angioplasty and drug eluting stent implantation according to local standard of care, including optimization techniques (e.g. post-dilatation) which are left at operators' discretion, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion. Receives: Device: Drug-eluting stent-based strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change of FFR values (ΔFFR)
Absolute change of fractional flow reserve (FFR) values (ΔFFR) measured at the final assessment immediately after the index PCI and invasive follow-up at 6(±30days) or 12(±30 days) months
Measured: At 6(±30days) or 12(±30 days) months after the index PCI
Secondary outcomes (22)
QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography
Minimal lumen diameter (MLD,mm) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography
Maximal diameter stenosis (MaxS, percent) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography
Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography.
Lesion length (LL, mm) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
QFR parameters before and after intervention and at follow-up angiography
Quantitative Flow Ratio (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
FFR parameters before and after intervention and at follow-up angiography
Fractional Flow Reserve (FFR) parameters before the intervention, immediately after the intervention and at follow-up angiography
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Minimal lumen diameter (MLD, mm)
Minimal lumen diameter (MLD, mm) evaluated with intravascular ultrasound (IVUS)
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Minimal luminal area (MLA, mm^2)
Minimal luminal area (MLA, mm^2) evaluated with intravascular ultrasound (IVUS)
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Maximal diameter stenosis (MaxS, percent)
Maximal diameter stenosis (MaxS, percent) evaluated with intravascular ultrasound (IVUS)
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Lumen volume (LV, mm^3)
Lumen volume (LV, mm^3) evaluated with intravascular ultrasound (IVUS)
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Vessel volume (VV, mm^3)
Vessel volume (VV, mm^3) evaluated with intravascular ultrasound (IVUS)
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Plaque burden (VV-LV)
Plaque burden (VV-LV) evaluated with intravascular ultrasound (IVUS)
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Late lumen loss (LLL)
Late lumen loss (LLL) evaluated with intravascular ultrasound (IVUS)
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Acute gain
Variation between pre treatment (T0) and immediately after the treatment (Tf)
Measured: pre procedure and immediately after the procedure
Disease progression after index PCI
Variation between final result of index PCI (Tf) and procedure at 6(±30days) or 12(±30 days) months after the index PCI (Tc)
Measured: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Target lesion revascularization (TLR) defined as urgent and non-urgent
Rate of target lesion revascularization (TLR) defined as urgent and non-urgent
Measured: 5 years after the index PCI
Target vessel revascularization (TVR), defined as urgent and non-urgent
Rate of target vessel revascularization (TVR), defined as urgent and non-urgent
Measured: 5 years after the index PCI
Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization
Rate of target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization
Measured: 5 years after the index PCI
The individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)
Rate of the individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)
Measured: 5 years after the index PCI
Any myocardial infarction
Rate of any myocardial infarction
Measured: 5 years after the index PCI
Stroke
Rate of stroke
Measured: 5 years after the index PCI
Definite or probable stent thrombosis
Rate of definite or probable stent thrombosis
Measured: 5 years after the index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start21 Feb 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiocentro Ticino
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Principal investigator, Marco Valgimigli, Cardiocentro Ticino
- Investigators
- Marco Valgimigli, M.D., Ph.D, Principal investigator, Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674630
- Sponsor's protocol ID
- 01_TITAN-DEB
- Acronym
- TITAN-DEB
- Status last verified
- Sep 2023
- First submitted
- 7 Dec 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons
- ClinicalTrials.gov ID
- NCT05674630
- Acronym / sponsor ID
- TITAN-DEB / 01_TITAN-DEB
- Conditions
- Chronic Coronary Syndrome
- Keywords
- adult, chronic coronary syndrome, percutaneous intervention, significant de novo coronary lesion, FFR≤0.80, iFR≤0.89, long DES (≥30 mm), coronary lesion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Cardiocentro TicinoUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 6 Jan 2023 (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 goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions.
Participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.
Detailed description
Patients at coronary angiography who are deemed suitable for PCI are assessed for eligibility. Patients fulfilling all inclusion and no exclusion criteria can be consented for trial participation. After successful lesion preparation, defined as residual stenosis less than 30%, TIMI flow 3 and no major (type C) dissection of target lesion, consented patients will be randomized in a 1:1 ratio to a drug eluting balloon(DEB)-based or standard drug eluting stent(DES)-based strategy and further randomized in a 1:1 fashion, stratified based on DEB vs DES, to undergo invasive follow-up at 6 (±30 days) or 12 (±30 days) months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up | Experimental | Device: Magic Touch drug eluting balloon based strategyPatients randomized to DEB-based strategy will receive treatment with DEB (Magic Touch, Concept Medical®) throughout the entire lesion length, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion. |
| Drug eluting stent based strategy - 6/12 months invasive follow up | Active comparator | Device: Drug-eluting stent-based strategyPercutaneous transluminal coronary angioplasty and drug eluting stent implantation according to local standard of care, including optimization techniques (e.g. post-dilatation) which are left at operators' discretion, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI
- At least one significant de-novo coronary lesion (defined as diameter stenosis > 50% on angiography, with flow limiting features, confirmed with FFR ≤0.80 or iFR ≤0.89 and intended implantation of a long (≥30 mm) DES based on IVUS findings
- Written informed consent
Key exclusion criteria (9 listed)
- Patients referred to the index procedure for an acute coronary syndrome
- Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery
- Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment
- Spontaneous coronary artery dissection (SCAD)
- Contraindications to adenosine administration (e.g. moderate to severe asthma or chronic obstructive pulmonary disease, heart rate <50 beats/min and systolic blood pressure <90 mmHg)
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 |
|---|---|---|
| Magic Touch drug eluting balloon based strategyAdult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the experimental arm will receive treatment with drug eluting balloon (Magic Touch®) followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion. | Device | Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up |
| Drug-eluting stent-based strategyAdult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the control arm will receive treatment with drug-eluting stent followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion. | Device | Drug eluting stent based strategy - 6/12 months invasive follow up |
Primary outcome
Absolute change of FFR values (ΔFFR)
Time frame: At 6(±30days) or 12(±30 days) months after the index PCI
Absolute change of fractional flow reserve (FFR) values (ΔFFR) measured at the final assessment immediately after the index PCI and invasive follow-up at 6(±30days) or 12(±30 days) months
22 secondary outcomes
QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
QFR parameters before and after intervention and at follow-up angiography
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
FFR parameters before and after intervention and at follow-up angiography
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Minimal lumen diameter (MLD, mm)
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Minimal luminal area (MLA, mm^2)
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Maximal diameter stenosis (MaxS, percent)
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Lumen volume (LV, mm^3)
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Vessel volume (VV, mm^3)
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Plaque burden (VV-LV)
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Late lumen loss (LLL)
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Acute gain
Time frame: pre procedure and immediately after the procedure
Disease progression after index PCI
Time frame: pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Target lesion revascularization (TLR) defined as urgent and non-urgent
Time frame: 5 years after the index PCI
Target vessel revascularization (TVR), defined as urgent and non-urgent
Time frame: 5 years after the index PCI
Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization
Time frame: 5 years after the index PCI
The individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)
Time frame: 5 years after the index PCI
Any myocardial infarction
Time frame: 5 years after the index PCI
Stroke
Time frame: 5 years after the index PCI
Definite or probable stent thrombosis
Time frame: 5 years after the index PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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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.
Enrico Frigoli, M.D. contact
Marco Valgimigli, M.D., Ph.D principal investigator
Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magic Touch drug eluting balloon based strategy and Drug-eluting stent-based strategy in people with Chronic Coronary Syndrome, run by Cardiocentro Ticino at 1 site in Switzerland.
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 9 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: looking for participants now, as of the sponsor's last update on 8 Sep 2023. 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 Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Valgimigli, M.D., Ph.D (+410918115111, marco.valgimigli@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change of FFR values (ΔFFR) (time frame: At 6(±30days) or 12(±30 days) months after the index PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2023.