Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06928883
NA

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

Sponsor: Cardiocentro Ticino

View on ClinicalTrials.gov

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

Official title: TITAN-PARADISE Pilot: TicIn for the Treatment of Coronary Lesions - Plaque Regression and Stabilization With Sirolimus Elution (Pilot Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-04

Completion Date

2028-12-31

Last Updated

2025-04-15

Healthy Volunteers

No

Interventions

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

Locations (1)

Istituto Cardiocentro Ticino - EOC

Lugano, Switzerland