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.
Optimal guidelines-directed medical therapies (GDMT): Optimal guidelines-directed medical therapies (GDMT) to reduce plaque burden and vulnerability for non-flow limiting vulnerable plaques
Study 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 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Absolute change in the IVUS-NIRS derived lipid core burden index (MAXLCBI4mm) between baseline and 6-months follow-up. — Between baseline and 6-months follow-up.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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