NCT06928883Not yet recruiting
Ticin Pilot Study: Sirolimus-Eluting Balloon for Stabilization and Regression of Non-Obstructive Coronary Plaques.
TITAN-PARADISE Pilot: TicIn for the Treatment of Coronary Lesions - Plaque Regression and Stabilization With Sirolimus Elution (Pilot Study)
Source: ClinicalTrials.gov · Last updated 15 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- Apr 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Cardiocentro Ticino
- Diseases
- Coronary artery disease
- NCT number
- NCT06928883
What you commit to
- Study type: Interventional
- Planned participants: 24
- From Apr 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non-culprit lesion in a previously stented segment (i.e. within 15 mm from the previously implanted stent);
- Partecipation in another clinical study with an investigational product
Other illness
- Life expectancy \<2 year due to other severe non-cardiac disease;
Lab values
- Severe renal impairment (eGFR\<15ml/min/1.73m2) or patient on dialysis treatment;
Other
- 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 involving small vessel (\<3.0 mm) deemed not suitable to PCI,
- Non-culprit lesion located in a bypass graft or in a grafted vessel;
- Known pregnancy r breast-feeding patients;
- Legally incompetent to provide informed consent;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Cardiocentro Ticino - EOC Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.