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

Cardiocentro Ticino

Status: Not yet enrolling

Conditions: Vulnerable Coronary Plaques; Multivessel Coronary Artery Disease; Coronary Arterial Disease (CAD); Acute Coronary Syndromes (ACS); Coronary Vessel

Treatments: Drug: Optimal guidelines-directed medical therapies (GDMT); Device: Sirolimus drug eluting ballooon therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06928883

TITAN-PARADISE Pilot

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Potential subjects must fulfill all following inclusion criteria:

1. Multivessel coronary artery disease with ACS within 90 days prior to inclusion and successful interventional treatment of the culprit lesion
2. 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
3. Age ≥ 18 years
4. Written informed consent

Exclusion criteria

Patients are not eligible if any of the following applies:

1. Non culprit lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery;
2. Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent);
3. Non-culprit lesion involving small vessel (<3.0 mm) deemed not suitable to PCI,
4. Non-culprit lesion located in a bypass graft or in a grafted vessel;
5. Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment;
6. Known pregnancy r breast-feeding patients;
7. Life expectancy <2 year due to other severe non-cardiac disease;
8. Legally incompetent to provide informed consent;
9. Partecipation in another clinical study with an investigational product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Sirolimus-eluting DEB (Selution SLR) therapy + Guidelines-directed medical therapy

Experimental group

Description:

Selution SLR sirolimus-eluting balloon additional to guidelines-directed medical therapy for the preventive treatment of non-flow limiting vulnerable coronary lesions

Treatment:

Device: Sirolimus drug eluting ballooon therapy

Guidelines-directed medical therapy

Active Comparator group

Description:

Guidelines-directed medical therapy

Treatment:

Drug: Optimal guidelines-directed medical therapies (GDMT)