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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardiocentro Ticino

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Sirolimus drug eluting ballooon therapy
  • Optimal guidelines-directed medical therapies (GDMT)

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators