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Not yet recruiting NCT06928883

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

No phase Interventional Coronary Arterial Disease (CAD) Vulnerable Coronary Plaques Multivessel Coronary Artery Disease Coronary Vessel

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sirolimus drug eluting ballooon therapy, Optimal guidelines-directed medical therapies (GDMT).
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Multivessel Coronary Artery Disease, Coronary Vessel. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device Sirolimus drug eluting ballooon therapy
    Non-flow limiting vulnerable coronary plaques are treated using sirolimus drug eluting balloon therapy additional to guidelines directed medical therapy.
  • Drug Optimal guidelines-directed medical therapies (GDMT)
    Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques

Primary outcome measures

  • 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 outcome measures (12)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Istituto Cardiocentro Ticino - EOC — Lugano

Identifiers

NCT: NCT06928883 · TITAN-PARADISE Pilot

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗