Trials / Not Yet Recruiting
Not Yet RecruitingNCT06928883
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)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Cardiocentro Ticino · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Coronary Arterial Disease (CAD)
- Vulnerable Coronary Plaques
- Multivessel Coronary Artery Disease
- Coronary Vessel
- Acute Coronary Syndromes (ACS)
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2027-09-30
- Completion
- 2028-12-31
- First posted
- 2025-04-15
- Last updated
- 2025-04-15
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT06928883. Inclusion in this directory is not an endorsement.