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NCT Number: NCT06928883

Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.

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

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Key information

Conditions

Coronary Arterial Disease (CAD) Acute Coronary Syndrome Acute Coronary Syndromes (ACS) Cardiovascular Diseases Coronary Vessel Heart Diseases Multivessel Coronary Artery Disease Myocardial Ischemia Vascular Diseases Vulnerable Coronary Plaques

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Cardiocentro Ticino - EOC

Lugano, 6900, Switzerland

Location contact

Enrico Frigoli, MD, MHS

CONTACT

[email protected]

+41 (0) 91 811 51 11

Marco Valgimigli, Md, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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;
  • 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

Treatment and study plan

Sirolimus drug eluting ballooon therapy

Device

Non-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy.

Other names: DEB-GDMT

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Minimal lumen diameter (MLD, mm) before the intervention, immediately after the intervention and at follow up angiography.

  2. 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.

    Maximal diameter stenosis (MaxS,%) before the intervention, immediately after the intervention and at follow up angiography.

  3. 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.

    Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow up angiography.

  4. 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.

    Lesion lenght (LL, mm) before the intervention, immediately after the intervention and at follow up angiography.

  5. 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.

    Quantitative Flow Ration (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography.

  6. 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.

    Minimal lumen diameter (MLD, mm) before the intervention, immediately after the intervention and at follow-up angiography.

  7. 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.

    Minimal lumen area (MLA, mm2) before the intervention, immediately after the intervention and at follow-up angiography.

  8. 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.

    Maximal diameter stenosis (MaxS, %) before the intervention, immediately after the intervention and at follow-up angiography.

  9. 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.

    Lumen volume (LV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.

  10. 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.

    Vessel volume (VV, mm3) before the intervention, immediately after the intervention and at follow-up angiography.

  11. 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.

    Plaque burden (VV-LV) before the intervention, immediately after the intervention and at follow-up angiography.

  12. 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.

    Late lumen loss (LLL) before the intervention, immediately after the intervention and at follow-up angiography.

  13. IVUS parameter (acute gain) before the intervention and immediately after the percutaneous intervention.

    Time frame: pre procedure and immediately after the procedure.

    Acute gain before the intervention (T0) and immediately after the percutaneous intervention (Tf).

  14. 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.

    Variation between the final result of index PCI (Tf) and procedure at 6(±30days) month follow-up (Tc).

  15. Target Lesion Revascularization (TLR)

    Time frame: During hospitalization and at 6(±30days) month follow-up.

    Rate of target lesion revascularization (TLR) defined as urgent and non urgent

  16. Target Vessel Revascularization (TVR)

    Time frame: During hospitalization and at 6(±30days) month follow-up.

    Rate of target vessel revascularization (TVR) defined as urgent and non-urgent.

  17. Target Vessel Failure (TVF)

    Time frame: During hospitalization and at 6(±30days) month follow-up.

    Rate of target vessel failure, defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization.

  18. 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.

    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).

  19. 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.

    Rate of major adverse cardiac events (MACE) defined as cardiac death, any myocardial infarction and any revascularization .

  20. 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.

    Rate of the individual components of the composite MACE endpoint (defined as cardiac death, any myocardial infarction, any revascularization).

  21. Stroke

    Time frame: 6(± 30 days) months after the index PCI.

    Rate of stroke.

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Frigoli Frigoli, MD, MHS

CONTACT

[email protected]

+41 (0) 91 811 51 11

Marco Valgimigli Marco Valgimigli, MD, PhD

CONTACT

[email protected]

+41 (0) 91 811 51 11

Sponsors and collaborators

Lead sponsor

Cardiocentro Ticino

Other

Registry information

Official study title

TITAN-PARADISE Pilot: TicIn for the Treatment of Coronary Lesions - Plaque Regression and Stabilization With Sirolimus Elution (Pilot Study)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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