Coronary Arterial Disease (CAD)NCT06928883
Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.
A study testing Sirolimus drug eluting ballooon therapy and Optimal guidelines-directed medical therapies (GDMT) in people with Coronary Arterial Disease (CAD) and Vulnerable Coronary Plaques, run by Cardiocentro Ticino at 1 site in Switzerland.
Trial summary
The goal of this pilot clinical trial is to evaluate the use of the Selution SLR sirolimus-eluting balloon, in addition to guideline-directed medical therapy (GDMT), for the preventive treatment of non-flow-limiting vulnerable coronary lesions, compared to GDMT alone, in adult patients with multivessel coronary artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Multivessel Coronary Artery Disease
- What is being tested?
- Sirolimus drug eluting ballooon therapy and Optimal guidelines-directed medical therapies (GDMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2025to 31 Dec 2028
- Phase
- Interventional
- 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
- Potential subjects must fulfill all following inclusion criteria:
- Multivessel coronary artery disease with ACS within 90 days prior to inclusion and successful interventional treatment of the culprit lesion
- Presence of ≥ 2 de novo non-culprit lesion without hemodynamic relevance in two different coronary vessels (demonstrated either by wire-based or angiography-based coronary physiology) and with MaxLCBI4mm ≥ 325 at baseline IVUS-NIRS
- Age ≥ 18 years
- Written informed consent
Who cannot join
- Patients are not eligible if any of the following applies:
- Non culprit lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery;
- Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent);
- Non-culprit lesion involving small vessel (<3.0 mm) deemed not suitable to PCI,
- Non-culprit lesion located in a bypass graft or in a grafted vessel;
- Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment;
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- Known pregnancy r breast-feeding patients;
- Life expectancy <2 year due to other severe non-cardiac disease;
- Legally incompetent to provide informed consent;
- Partecipation 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.
Switzerland1 site
Istituto Cardiocentro Ticino - EOC
Lugano, 6900
Enrico Frigoli, MD, MHS, +41 (0) 91 811 51 11, enrico.frigoli@eoc.ch
Marco Valgimigli, Md, PhD
About this study
Official title: TITAN-PARADISE Pilot: TicIn for the Treatment of Coronary Lesions - Plaque Regression and Stabilization With Sirolimus Elution (Pilot Study)
The goal of this pilot clinical trial is to evaluate the use of the Selution SLR sirolimus-eluting balloon, in addition to guideline-directed medical therapy (GDMT), for the preventive treatment of non-flow-limiting vulnerable coronary lesions, compared to GDMT alone, in adult patients with multivessel coronary artery disease and a recent acute coronary syndrome (within 90 days).
The main research question is:
Read more
Does the use of the Selution SLR sirolimus-eluting balloon in combination with GDMT reduce the progression and vulnerability of non-flow-limiting vulnerable coronary plaques?
Participants will undergo
- PCI procedure with baseline IVUS-NIRS assessment
- Follow-up coronary angiography at 6 months with IVUS-NIRS assessment
- Clinical follow-up at 3, 6, and 24 months after study enrollment
- Conditions
- Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Multivessel Coronary Artery Disease, Coronary Vessel, Acute Coronary Syndromes (ACS)
- Being tested
- Sirolimus drug eluting ballooon therapy, Optimal guidelines-directed medical therapies (GDMT)
- Keywords
- Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Multivessel coronary artery disease, Coronary vessel, Acute Coronary Syndromes (ACS), Non-flow limiting vulnerable coronary plaques, Sirolimus-eluting DEB, DEB Selution SLR, Guidelines-directed medical therapies (GDMT), IVUS-NIRS, MaxLCBI4mm, MaxLCBI4mm≥325, Lipid Core Burden Index (LCBI)
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus drug eluting ballooon therapyDevice
Also called DEB-GDMT
Non-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy.
Optimal guidelines-directed medical therapies (GDMT)Drug
Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus-eluting DEB (Selution SLR) therapy + Guidelines-directed medical therapy | Experimental | Selution SLR sirolimus-eluting balloon additional to guidelines-directed medical therapy for the preventive treatment of non-flow limiting vulnerable coronary lesions Receives: Device: Sirolimus drug eluting ballooon therapy |
| Guidelines-directed medical therapy | Active comparator | Guidelines-directed medical therapy Receives: Drug: Optimal guidelines-directed medical therapies (GDMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in the IVUS-NIRS derived lipid core burden index (MAXLCBI4mm) between baseline and 6-months follow-up.
Measured: Between baseline and 6-months follow-up.
Secondary outcomes (21)
QCA parameter (minimal lumen diameter, MLD, mm) before and after 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(±30 days) months follow-up.
QCA parameter (maximal diameter stenosis, MaxS,%) before and after intervention and at follow-up angiography.
Maximal diameter stenosis (MaxS,%) before the intervention, immediately after the intervention and at follow up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
QCA parameter (reference vessel diameter, RVD, mm) before and after 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(±30 days) months follow-up.
QCA parameter (lesion lenght, LL, mm) before and after intervention and at follow-up angiography.
Lesion lenght (LL, mm) before the intervention, immediately after the intervention and at follow up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
QFR parameters before and after the intervention and at follow-up angiography
Quantitative Flow Ration (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) months follow-up.
IVUS parameter (minimal lumen diameter, MLD, mm) before the intervention, immediately 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) months follow-up.
IVUS parameter (minimal lumen area, MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography.
Minimal lumen area (MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (maximal diameter stenosis, MaxS,%) before the intervention, immediately after the intervention and at follow-up angiography.
Maximal diameter stenosis (MaxS, %) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (lumen volume, LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.
Lumen volume (LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (vessel volume, VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.
Vessel volume (VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (plaque burden, VV-LV) before the intervention, immediately after the intervention and at follow-up angiography.
Plaque burden (VV-LV) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (late lumen loss, LLL) before the intervention, immediately after the intervention and at follow-up angiography.
Late lumen loss (LLL) before the intervention, immediately after the intervention and at follow-up angiography.
Measured: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (acute gain) before the intervention and immediately after the percutaneous intervention.
Acute gain before the intervention (T0) and immediately after the percutaneous intervention (Tf).
Measured: pre procedure and immediately after the procedure.
IVUS parameter (disease progression) after the final result of index PCI (Tf) and at 6(±30days) month follow-up procedure.
Variation between the final result of index PCI (Tf) and procedure at 6(±30days) month follow-up (Tc).
Measured: immediately after the procedure and at 6(±30 days) months after the index PCI.
Target Lesion Revascularization (TLR)
Rate of target lesion revascularization (TLR) defined as urgent and non urgent
Measured: During hospitalization and at 6(±30days) month follow-up.
Target Vessel Revascularization (TVR)
Rate of target vessel revascularization (TVR) defined as urgent and non-urgent.
Measured: During hospitalization and at 6(±30days) month follow-up.
Target Vessel Failure (TVF)
Rate of target vessel failure, defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization.
Measured: During hospitalization and at 6(±30days) month follow-up.
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: During hospitalization and at 6(±30days) month follow-up.
Major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization.
Rate of major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization .
Measured: 6(± 30 days) months after the index PCI.
The individual components of the composite major adverse cardiac events (MACE- defined as cardiac death, any myocardial infarction and any revascularization).
Rate of the individual components of the composite MACE endpoint (defined as cardiac death, any myocardial infarction, any revascularization).
Measured: 6(± 30 days) months after the index PCI.
Stroke
Rate of stroke.
Measured: 6(± 30 days) months 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 posted15 Apr 2025
- Study startApr 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiocentro Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Valgimigli, Cardiocentro Ticino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928883
- Sponsor's protocol ID
- TITAN-PARADISE Pilot
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The final study data will be disseminated to the scientific community through the publication of results in peer-reviewed journals, ensuring accessibility to researchers and healthcare professionals.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TITAN-PARADISE Pilot: TicIn for the Treatment of Coronary Lesions - Plaque Regression and Stabilization With Sirolimus Elution (Pilot Study)
- ClinicalTrials.gov ID
- NCT06928883
- Acronym / sponsor ID
- TITAN-PARADISE Pilot
- Conditions
- Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Multivessel Coronary Artery Disease, Coronary Vessel, Acute Coronary Syndromes (ACS)
- Keywords
- Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Multivessel coronary artery disease, Coronary vessel, Acute Coronary Syndromes (ACS), Non-flow limiting vulnerable coronary plaques, Sirolimus-eluting DEB, DEB Selution SLR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cardiocentro TicinoUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Apr 2025 (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 pilot clinical trial is to evaluate the use of the Selution SLR sirolimus-eluting balloon, in addition to guideline-directed medical therapy (GDMT), for the preventive treatment of non-flow-limiting vulnerable coronary lesions, compared to GDMT alone, in adult patients with multivessel coronary artery disease and a recent acute coronary syndrome (within 90 days).
The main research question is:
Does the use of the Selution SLR sirolimus-eluting balloon in combination with GDMT reduce the progression and vulnerability of non-flow-limiting vulnerable coronary plaques?
Participants will undergo
- PCI procedure with baseline IVUS-NIRS assessment
- Follow-up coronary angiography at 6 months with IVUS-NIRS assessment
- Clinical follow-up at 3, 6, and 24 months after study enrollment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus-eluting DEB (Selution SLR) therapy + Guidelines-directed medical therapy | Experimental | Device: Sirolimus drug eluting ballooon therapySelution SLR sirolimus-eluting balloon additional to guidelines-directed medical therapy for the preventive treatment of non-flow limiting vulnerable coronary lesions |
| Guidelines-directed medical therapy | Active comparator | Drug: Optimal guidelines-directed medical therapies (GDMT)Guidelines-directed medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Multivessel coronary artery disease with ACS within 90 days prior to inclusion and successful interventional treatment of the culprit lesion
- Presence of ≥ 2 de novo non-culprit lesion without hemodynamic relevance in two different coronary vessels (demonstrated either by wire-based or angiography-based coronary physiology) and with MaxLCBI4mm ≥ 325 at baseline IVUS-NIRS
- Age ≥ 18 years
- Written informed consent
Key exclusion criteria (10 listed)
- Non culprit lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery;
- Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent);
- Non-culprit lesion involving small vessel (<3.0 mm) deemed not suitable to PCI,
- Non-culprit lesion located in a bypass graft or in a grafted vessel;
- Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis 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 drug eluting ballooon therapyAlso: DEB-GDMTNon-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy. | Device | Sirolimus-eluting DEB (Selution SLR) therapy + Guidelines-directed medical therapy |
| Optimal guidelines-directed medical therapies (GDMT)Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques | Drug | Guidelines-directed medical therapy |
Primary outcome
Absolute change in the IVUS-NIRS derived lipid core burden index (MAXLCBI4mm) between baseline and 6-months follow-up.
Time frame: Between baseline and 6-months follow-up.
21 secondary outcomes
QCA parameter (minimal lumen diameter, MLD, mm) before and after intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
QCA parameter (maximal diameter stenosis, MaxS,%) before and after intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
QCA parameter (reference vessel diameter, RVD, mm) before and after intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
QCA parameter (lesion lenght, LL, mm) before and after intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30 days) months follow-up.
QFR parameters before and after the intervention and at follow-up angiography
Time frame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (minimal lumen diameter, MLD, mm) before the intervention, immediately after the intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (minimal lumen area, MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (maximal diameter stenosis, MaxS,%) before the intervention, immediately after the intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (lumen volume, LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (vessel volume, VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (plaque burden, VV-LV) before the intervention, immediately after the intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (late lumen loss, LLL) before the intervention, immediately after the intervention and at follow-up angiography.
Time frame: pre procedure, immediately after the procedure and at 6(±30days) months follow-up.
IVUS parameter (acute gain) before the intervention and immediately after the percutaneous intervention.
Time frame: pre procedure and immediately after the procedure.
IVUS parameter (disease progression) after the final result of index PCI (Tf) and at 6(±30days) month follow-up procedure.
Time frame: immediately after the procedure and at 6(±30 days) months after the index PCI.
Target Lesion Revascularization (TLR)
Time frame: During hospitalization and at 6(±30days) month follow-up.
Target Vessel Revascularization (TVR)
Time frame: During hospitalization and at 6(±30days) month follow-up.
Target Vessel Failure (TVF)
Time frame: During hospitalization and at 6(±30days) month follow-up.
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: During hospitalization and at 6(±30days) month follow-up.
Major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization.
Time frame: 6(± 30 days) months after the index PCI.
The individual components of the composite major adverse cardiac events (MACE- defined as cardiac death, any myocardial infarction and any revascularization).
Time frame: 6(± 30 days) months after the index PCI.
Stroke
Time frame: 6(± 30 days) months 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 15 Apr 2025.
- Individual participant dataSharing planned: No. The final study data will be disseminated to the scientific community through the publication of results in peer-reviewed journals, ensuring accessibility to researchers and healthcare professionals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus drug eluting ballooon therapy and Optimal guidelines-directed medical therapies (GDMT) in people with Coronary Arterial Disease (CAD) and Vulnerable Coronary Plaques, 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 15 Apr 2025. 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.
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 Marco Valgimigli, MD, PhD (+41 (0) 91 811 51 11, 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 in the IVUS-NIRS derived lipid core burden index (MAXLCBI4mm) between baseline and 6-months follow-up. (time frame: Between baseline and 6-months follow-up.). 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 15 Apr 2025.